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This is the retyped text of a letter released by Menlo Care, Inc. Contact the company for a copy of any referenced enclosures.

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Since its introduction in January 1989, Menlo Care has received 173 reports of adverse events either during or within 30 minutes of the placement and flushing of the LANDMARK Midline Catheter. These events range from minor signs and symptoms to rare life-threatening incidents. During this same period, Menlo Care shipped 726,000 catheters. The frequency of reports is such that you should be prepared to initiate appropriate medical intervention if an adverse event occurs.

The most frequently reported signs and symptoms include:

• flushing of the face, which may progress to the neck and torso;
• pain, including chest pain or tightness, abdominal pain, and back pain;
• breathing difficulties including shortness of breath, respiratory distress, and throat tightness;
• diaphoresis;
• hives/welts or rash;
• cyanosis; and/or
• alterations in vital signs, more commonly hypotension.
  

Other signs and symptoms less frequently reported include:

• respiratory changes, such as wheezing, coughing, sneezing, head/neck/oropharynx swelling;
• circulatory changes such as pallor;
• neurological changes such as restlessness, loss of consciousness, seizures, agitation, tingling sensations and lightheadedness;
• gastrointestinal changes such as nausea and vomiting; and/or
• dermatological changes such as mottling of skin and itching.

Some rare events have been reported to Menlo Care, Inc. These events include four reports of cardiac arrest and three reports of respiratory arrest.

The cause of these adverse events is not known at this time. These signs and symptoms both resolved with removal of the catheter and while the catheter was still in place. For some patients, medical intervention such as parenteral epinephrine or other drugs, has been the course of action. Case reports in the literature about midline catheters have also described trauma to the vessel during the insertion and advancement of the catheter, hyperventilation, anxiety, vasovagal reactions, and reactions associated with the infusion of medications and flushing solutions as causing some of these same signs and symptoms.

Menlo Care and the Food and Drug Administration (FDA) are working together to try to understand the nature of the events and how to prevent them. Testing has not indicated any sensitivity or allergy to the device material. A comparative study of midline catheters is being planned for 1996.

In the meantime, Menlo Care has been emphasizing a slower insertion with constant flushing during the advancement of the midline catheter as a possible means of minimizing adverse events. In January 1994, Menlo Care began an education program to emphasize this technique and the reports of adverse events to the company have declined since that time. A copy of our current insertion procedure, including precautions and warnings is included.

Malfunctions, serious illnesses and injuries, and deaths that take place as a result of or during the use of any catheter should be reported to the device manufacturer. The Safe Medical Devices Act (SMDA) requires hospitals and other user facilities to report deaths, serious illnesses and serious injuries in which a medical device may have caused or contributed to the adverse event. Practitioners who become aware of any medical device-related adverse event or product problem/malfunction should report to their Medical Device User Facility Reporting contact person. In addition, health-care practitioners may report medical device problems directly to MedWatch, the FDA's voluntary reporting program.

Submit these reports to MedWatch:

• by phone, at 1-800-FDA-1088,
• by FAX at 1-800-FDA-0178, or
• mail to:
  MedWatch, FDA
  HF-2
  5600 Fishers Lane
  Rockville, MD 20857.

If you experience any adverse patient responses or problems with Menlo Care products or if you have any questions regarding this letter, please contact Menlo Care, Inc. at 1-800-752-8900.

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