PERIFIX®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: FAILURE TO INSERT CATHETER AND REMOVE CATHETER, DISTAL END MISSING (PROBABLY CUT ON TUOHY NEEDLE). NO CONSEQUENCES INITIALLY (PATIENT INFORMED OF THE END OF THE KT REMAINING IN PLACE, MONITORING AND INSTRUCTIONS TO CONSULT AGAIN AT THE SLIGHTEST DOUBT).

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. WITH THE BATCH NUMBER 24K16A8701 WERE PRODUCE 33,280. SETS FOR ORDER NO. (B)(4). 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 IN THE MENTIONED TIME PERIOD. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: NO SAMPLE WAS RECEIVED AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. SUMMARY AND ASSESSMENT: AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. THE INVESTIGATION SAMPLE(S) IS/ARE NOT AVAILABLE.