TOTAL ABSCESSION

Description of Event or Problem

CATHETER BROKE IN HALF. ALCOHOL, HOWEVER, WAS USED AND RAN THRU THE CATHETER TO SCLEROSE A CYST.

Additional Manufacturer Narrative

LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT REPORTED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED CATALOG NUMBER. THERE WAS ONLY ONE LOT SHIPPED TO THE COMPLAINANT 3 MONTHS BEFORE THE REPORTED INCIDENT DATE: (B) (4). THE POSSIBLE LOT NUMBER WAS REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING FOUND THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE FOLLOWING WAS OBSERVED: THE COMPLAINT SAMPLE WAS RETURNED IN TWO PIECES. THE FIRST SECTION IS THE HUB AND PART OF THE SHAFT. THIS SECTION IS 12CM IN LENGTH. THE SUTURE WIRE IS COILED AND KNOTTED AROUND THE SHAFT. THE DISTAL TIP OF THIS SECTION IS JAGGED. THE SECOND SECTION IS 12.5 CM OF THE DISTAL PORTION OF THE CATHETER. THE PROXIMAL END IS TORN AND JAGGED. THERE IS A 3CM JAGGED TEAR IN THE CATHETER SHAFT. THE SUTURE HOLES AT THE DISTAL TIP ARE TORN AND JAGGED. IT APPEARS AS IF THE SUTURE WIRE TORE THROUGH THE CATHETER SHAFT. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VITAL INSPECTION OF THE RETURNED SAMPLE. THE COMPLAINT SAMPLE WAS RETURNED IN TWO PIECES. BASED ON THIS INFORMATION PROVIDED, IT APPEARS AS IF THE COMPLAINT IS USER RELATED. ALCOHOL WAS USED AND RAN THRU THE CATHETER TO SCLEROSES A CYST. THE LABELING AND INSTRUCTIONS FOR USE BOTH STATE THE FOLLOWING WARNING: "DO NOT USE THIS CATHETER WITH ALCOHOL". THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.