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. ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER. 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 PAED Ø0,84MM (20G) 50MM P IS TORN / SHEARED OFF. THE TORN OFF PART WITH THE CATHETER TIP WAS NOT HANDED OVER BY THE CUSTOMER. THE RECEIVED CATHETER PART IS APPROX. 1006 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 NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF.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 (PM: 43789). 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: 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.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE 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.

Description of Event or Problem

ACCORDING TO THE CUSTOMER: "THE CATHETER GETS STUCK AT THE EXIT AND WHEN IT IS REMOVED IT FRACTURES. THE NEEDLE IS WASHED, BUT IT IS RULED OUT THAT THE REMNANT IS INSIDE IT, SO IT IS PRESUMED THAT IT REMAINED INSIDE THE PATIENT, MOST LIKELY OUTSIDE THE NEURON ILA SPACE. ULTRASOUND AND RX WERE PERFORMED AND NO REMAINS OF THE CATHETER WERE VISIBLE."