PERIFIX®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "ANALGESIC EPIDURAL PLACEMENT FOR VAGINAL DELIVERY. SINGLE PUNCTURE WITH PALPABLE LANDMARK AT L2-L3 SPACE, 5 CM DEPTH. DURING NEEDLE WITHDRAWAL, DURING A CONTRACTION, THE CATHETER WAS SEVERED OVER A LENGTH OF 9 CM."

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4).

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED PERIFIX ONE Ø0,45X0,85, 20G S-O NL OUT OF A PERIFIX ONE 401 FILTER SET NRFIT-EU SET WITHOUT PACKAGING WAS RECEIVED. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE USED PERIFIX ONE CATHETER IS SHEARED OFF. ACCORDING TO THE CUSTOMER THE SHEARED OFF PART WITH THE CATHETER TIP REMAINED IN THE LIGAMENTUM FLAVUM OF THE PATIENT. THE SHEARED OFF AREA AT THE RECEIVED CATHETER SHOWS A V-SHAPED, AND IT IS ASSUMED THAT THE STRUCTURE WAS CAUSED BY THE RETRACTION OF THE CATHETER IN THE CANNULA. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. AS FOUND IN THE INSTRUCTIONS FOR USE: "NEVER PULL THE CATHETER BACK THROUGH THE CANNULA, AS IT COULD BE SHEARED OFF". PHYSICAL INSPECTION: AFTERWARDS, THE LENGTH OF THE CATHETER WITHOUT DAMAGES WAS MEASURED. NOMINAL: 1010 MM (+7.5 MM / -7.5 MM). ACTUAL: 913 MM. IN ADDITION, THE OUTER DIAMETER OF THE RECEIVED USED PERIFIX ONE CATHETER WAS MEASURED ACCORDING TO THE DRAWING. NOMINAL: 0.84 MM / +/- 0.04 MM. ACTUAL: OUTER DIAMETER IN SEVERAL AREAS: BETWEEN 0.83 MM - 0.84 MM. THE MEASURED VALUE OF THE CATHETERS IS WITHIN THE SPECIFICATIONS. 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, A PROBLEM DURING THE APPLICATION PROCESS IS ASSUMED. BUT RELATING TO THE DAMAGED CATHETER THE DEFECT IS CONSIDERED AS CONFIRMED. ACCORDING TO THE CUSTOMER 3 BATCHES POSSIBLE: 25A17A8701 OR 25E12A8701 OR 25B10A87015 (THREE BATCHES PRESENT IN THE ANESTHESIA DEPARTMENT - PACKAGING NOT RETAINED, HENCE UNCERTAINTY ABOUT THE EXACT BATCH). AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION (SHIFT RECORD, RESULTS OF WORKER SELF-INSPECTION AND IN-PROCESS CONTROL, MACHINE DOCUMENTATION, CLEANING RECORD ETC.) NO DEVIATIONS COULD BE IDENTIFIED. NOTE: THIS REPORTED 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.