PERIFIX®

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: WHEN THE PERIDUAL CATHETER IS REMOVED, IT IS FOUND TO BE INCOMPLETE. STANDARD PROCEDURE FOR REMOVAL. SPECIAL FEATURE: THE PATIENT ARCHED HER BACK AT ONE POINT, THEN AFTER REPOSITIONING, THE CATHETER WAS EASILY REMOVED. CLINICAL CONSEQUENCES: PATIENT REMAINED TOTALLY ASYMPTOMATIC, NEUROLOGICAL EXAMINATION WITHOUT ABNORMALITY. PATIENT DISCHARGED ON (B)(6) 2024 WITH INSTRUCTIONS TO RECALL IF PAIN OR OTHER NEUROLOGICAL SYMPTOMS. PATIENT INFORMED OF SITUATION. LUMBAR MRI PERFORMED ON (B)(6) 2024 WITH NO ABNORMALITIES AND NO EPIDURAL FOREIGN BODY, SUPPLEMENTED BY A STANDARD FACE + PROFILE X-RAY RETURNED NORMAL. NO CONSEQUENCE FOR THE PATIENT.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). BATCH REVIEW FROM HC-PM-DE08A OF 2024-07-17 MR (B)(6). WITH THE BATCH NUMBER 24A16A8701 WERE PRODUCE 12.480 SETS FOR ORDER NO. 1245607. 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. HC-PM COMPLAINT PROCESSING RECEIVED NO SAMPLE AND NO PICTURE. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: NO SAMPLE WAS RECEIVED AND THUS A FURTHER EVALUATION AND INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: N.A. 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. 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.