JELCO® VIAVALVE® SAFETY IV CATHETERS

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

IT WAS REPORTED THAT A JELCO® VIAVALVE® SAFETY IV CATHETER SEVERED LEAVING "REMAINS OF THE CATHETER" IN A PATIENT. THE INTRAVENOUS CATHETER "WAS INTERSTITIAL". THE "REMAINS OF THE CATHETER" WERE REMOVED UNDER COMPUTED TOMOGRAPHY BY A VASCULAR SURGEON BY MEANS OF A SMALL INCISION. NO OTHER ADVERSE HEALTH EVENTS WERE REPORTED.

Additional Manufacturer Narrative

ONE USED VIAVALVE® CATHETER WITH AN EXTENSION SET ATTACHED WAS RECEIVED FOR INVESTIGATION. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS UNKNOWN. DURING INCOMING INSPECTION, THE INVESTIGATION OBSERVED THAT THE DETACHED SEGMENT OF THE CATHETER WAS NOT INCLUDED FOR EXAMINATION. A VISUAL INSPECTION OF THE CATHETER WAS PERFORMED UNDER MICROSCOPY REVEALING DISTINCT DAMAGE ON THE EDGE OF THE NOSE AND THAT THE CATHETER TUBE WAS SEVERED ABOVE THE HUB NOSE. THE INVESTIGATION DID CONFIRM THAT THE PRODUCT FAILED TO MEET THE EXPECTED PERFORMANCE. BASED ON THE EVIDENCE THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED SINCE THE LOT NUMBER WAS UNKNOWN, THE SEPARATED PIECE WAS UNAVAILABLE FOR INVESTIGATION AND THE CONDITION OF THE PART RECEIVED COULD NOT BE REPLICATED BY SUBJECT MATTER EXPERIENCED PROFESSIONALS. WITH NO MANUFACTURING-RELATED POTENTIAL ROOT CAUSES IDENTIFIED DURING THIS INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS HAVE BEEN ASSIGNED AT THIS TIME AND COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED.