PERIFIX®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: THE DOCTOR INSERTED THE CATHETER AND FOUND THAT IT WAS PLACED TOO DEEPLY. THEN DOCTOR REMOVED CATHETER FROM THE PATIENT, AND IT WAS FOUND TO BE STRETCHED AND BROKEN.

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. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED CUSTOMER PICTURES WERE 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 FIRST CUSTOMER PICTURE SHOWS AN OVERSTRETCHED CATHETER WHERE THE CATHETER END IS SUPPOSED TO BE TORN OFF, WHICH CANNOT BE SEEN IN THE CUSTOMER PICTURE, AND A COMPARISON SAMPLE, SEE CUSTOMER PICTURE. THE SECOND CUSTOMER PICTURE SHOWS THE PACKAGE WITH THE VARIABLE DATA. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF.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." BATCH HISTORY REVIEW: PERIFIX ONE PAED SET (B)(6). REF.: 4512014CX. LOT.: 22A25A8701. PERIFIX ONE PAED Ã[?]0,59MM (24G) 50MM P. REF.: 8445819. LOT.: 22A18A6561, 22A19A6561, 22A20A6561, 21L27A6561. FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: N.A. 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. THEREFORE, WE ASSUME A FAULT DURING THE APPLICATION PROCESS AND WE CONSIDER THE COMPLAINT AS NOT CONFIRMED. BASED ON THE CONDUCTED INVESTIGATIONS THE RECEIVED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE INVESTIGATION SAMPLE(S) IS/ARE NOT AVAILABLE.