PERIFIX®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: DURING DURAL ANESTHESIA, THE CATHETER GOES IN 20 CENTIMETERS AND EXITS ABOUT 10 CENTIMETERS INTO THE PATIENT'S BODY. THE DOCTOR SAID THAT THE CATHETER INSERTION WENT SMOOTHLY DURING ANESTHESIA. AFTER GIVING BIRTH, PREGNANT WOMEN ARE SENT TO SURGERY TO REMOVE THE BROKEN PART.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. COMPLAINT PROCESSING DEPARTMENT RECEIVED ONE USED PERIDURALKAT.GRADUIERT 20G"S-O" WITHOUT PACKAGING OUT OF A PERIFIX 301 G18 MINI SET/LOR STECK AND ONE OPTICAL UNUSED PERIDURALKAT.GRADUIERT 20G"S-O" AS A REFERENCE SAMPLE. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED CATHETERS OUT OF THE SET WERE TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD 102002 DAMAGES. THE USED PERIDURALKAT.GRADUIERT 20G"S-O" IS SHEARED OFF. THE LONGER PART OF THE CATHETER IS APPROX. 933 MM LONG (SHOULD BE 1010 MM +60 -20 COMPLETELY). THE SHEARED OFF PART IS APPROX. 108 MM LONG. AT THE REFERENCE SAMPLE NO DAMAGES OR MANUFACTURING FAULTS WERE DETECTED. THE REFERENCE SAMPLE WAS ONLY TAKEN TO KNOWLEDGE AND WILL NOT BE INVESTIGATED FURTHER. BATCH HISTORY REVIEW: PERIFIX 301 G18 MINI SET/LOR STECK. REF.: (B)(4) LOT.: 23K26A8701. PERIDURALKAT.GRADUIERT 20G"S-O". REF.: (B)(4), LOT.: 23E09A6561, 23E12A6561. NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. PLEASE SEE INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF." PHYSICAL INSPECTION: IN ADDITION, THE OUTER DIAMETER OF THE USED CATHETER WAS MEASURED ACCORDING TO THE DRAWING. NOMINAL: 0.84 MM +/- 0.04 MM. ACTUAL: OUTER DIAMETER IN SEVERAL AREAS: 0.85 - 0.86 MM. THE MEASURED VALUE OF THE CATHETER IS WITHIN THE SPECIFICATIONS. SUMMARY AND ASSESSMENT: A MANUFACTURING FAULT IS EXCLUDED, SINCE THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. BECAUSE OF THIS, IT IS ASSUMED THERE WAS A PROBLEM DURING THE APPLICATION PROCESS. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.