JELCO® JELCO® I.V. CATHETER

Additional Manufacturer Narrative

REPORT SOURCE: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT A DEATH OCCURRED FROM MULTIPLE ATTEMPTS AT CANNULATION USING A JELCO® JELCO® I.V. CATHETER. THE DEATH OCCURRED IN A HOSPITAL. THE ISSUE WAS REPORTED BY TWO DOCTORS AND A HOSPITAL STAFF. THIS BATCH OF PRODUCT WAS "TROUBLESOME" AND "REQUIRES INSPECTION". THIS BATCH WAS PACKAGED DIFFERENTLY THAN USUAL WITH A STICKER ON IT INDICATING THAT IT WAS IMPORTED TO (B)(4) AND SUBSEQUENTLY TO (B)(4). THE PATIENT "BECAME A NIGHTMARE TO DRIP" AND EVENTUALLY "HAD NO SITES LEFT TO CANNULATE". MULTIPLE INTRAVENOUS ATTEMPTS WERE MADE IN THE LAST 2 WEEKS PRIOR TO DEMISE. PART OF THE SEPSIS ISSUES IN THIS PATIENT MAY HAVE BEEN THE MULTIPLE ATTEMPTS/SKIN PUNCTURES REQUIRED FOR CANNULATION.

Additional Manufacturer Narrative

TWO JELCO® I.V. CATHETERS IN A CLOSED BLISTER POUCH WERE RECEIVED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO NON-CONFORMANCES WERE NOTED. FUNCTIONAL TESTING OF THE RETURNED SAMPLES FOUND NO DEFECTS. THE FLASHBACK OCCURRED WITHIN THE TIME REQUESTED BY THE PRODUCT SPECIFICATION. THE COMPLAINT WAS NOT CONFIRMED. A POSSIBLE ROOT CAUSE WOULD BE THE USER ATTEMPTING CANNULATION MULTIPLE TIMES (AS STATED BY THE REPORTER), INSTEAD OF JUST ONCE AS STATED IN THE DEVICE INSTRUCTIONS FOR USE.