PERIFIX®

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. WE RECEIVED ONE USED PERIFIX ONE Ø0,84MM (20G) 80MM P OUT OF A PERIFIX ONE 401 FILTER SET WITHOUT PACKAGING AND 3 X-RAY FROM THE CUSTOMER. BECAUSE WE RECEIVED NO BATCH INFORMATION FROM THE CUSTOMER, AN EXAMINATION IS NOT POSSIBLE IF THERE WERE ANY ABNORMALITIES IN THE MANUFACTURING PROCESS OR IN THE CHECK ROUTINE OF THE FINAL CONTROL. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED CATHETER OUT OF THE SET WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD 102002_DAMAGES. DEFINITION OF THE METHOD: DAMAGES ARE VISIBLE CHANGES IN THE ORIGINAL SHAPE OR SURFACE OF PRODUCTS AND PACKAGING CAUSED BY MECHANICAL FORCES AND/OR MANUFACTURING FAULTS. NOMINAL: NO DAMAGE IS ALLOWED THAT ENDANGERS THE PATIENT, IMPEDES THE USE OF THE PART AS INTENDED (E.G. THE IMPAIRMENT OF THE FUNCTION OF A DROP SENSOR), ENDANGERS THE ASSEMBLY OR FUNCTION OF THE COMPONENT, IMPAIRS THE APPEARANCE OF THE COMPONENT. ACTUAL: THE USED PERIFIX ONE Ø0,84MM (20G) 80MM P IS TORN / SHEARED OFF. THE TORN OFF PART WITH THE CATHETER TIP WAS NOT HANDED OVER BY THE CUSTOMER. THE CATHETER END WAS ALSO CUT OFF AND NOT HANDOVER BY THE CUSTOMER. THE RECEIVED CATHETER PART IS APPROX. 310 MM LONG (SHOULD BE 1010 MM +- 7.5 MM COMPLETELY, PM: 1806). THE SHORN OFF AREA AT THE CATHETER TIP IS SLANTED. THE SEPARATED AREA IS SLANTED, AND THE STRUCTURE IS DUE TO THE RETRACTION OF THE CATHETER IN THE CANNULA. NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF.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." FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: IN ADDITION, THE OUTER DIAMETER OF THE PERIFIX CATHETER WAS MEASURED ACCORDING TO THE DRAWING. THE MEASURED VALUE OF THE CATHETER IS WITHIN THE SPECIFICATIONS. SUMMARY AND ASSESSMENT: WE EXCLUDE A MANUFACTURING FAULT SINCE THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. BECAUSE OF THIS WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

Description of Event or Problem

ACCORDING TO THE COMPLAINANT AN EPIDURAL CATHETER PLACEMENT WAS PERFORMED ON THE NIGHT ON (B)(6) 2024. THE PLACEMENT WAS WITHOUT AN ISSUE. ONE PUNCTURE, CATHETER INSERTION WITHOUT DIFFICULTY, EFFECTIVE EPIDURAL ANALGESIA. REPORTEDLY THE CATHETER WAS REMOVED WITHOUT DIFFICULTY OR TRACTION. UPON REMOVAL THE DEVICE WAS MISSING 5 MILLIMETERS (MM) AT THE END OF THE CATHETER. AN ULTRASOUND AND CT SCAN WERE PERFORMED AND NOTHING WAS VISIBLE. THE FRAGMENT REMAINED IN THE PATIENT'S EPIDURAL SPACE.