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. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR THE BATCH NUMBER 21B21G0F6Y, NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS AND FINAL CONTROL INSPECTION. SAMPLE RECEIVED AT BMI: 2024-08-09. RECEIVED 1 SAMPLE OF PERICAN TUOHY D1,3X80 G18G BULK NON STER TOGETHER WITH A CATHETER WITHOUT ORIGINAL PRIMARY PACKAGING. UPON VISUAL CHECKING, NO DAMAGES DETECTED ON THE PERICAN TUOHY NEEDLE. HC-PM COMPLAINT PROCESSING RECEIVED NO SAMPLE, WE RECEIVED 8 CUSTOMER PICTURES OF A USED PERIFIX EPIDURAL CATHETER 20G OUT OF AN PERIDURAL-SET SPITALREG. FUERSTENLAND-TO (ATTACHED IN THE PC-NOTIFICATION). 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 CUSTOMER PICTURES SHOWS A TORN OFF CATHETER. THE SHORN OFF AREA IS SLANTED AND SHOWS A SMOOTH STRUCTURE. NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF.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: 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. BASED ON THE CONDUCTED INVESTIGATIONS THE CHECKED SAMPLE IN THE PICTURES IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME 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

AS DESCRIBED IN THE COMPLAINT DESCRIPTION: ON (B)(6) 2024 AROUND 04:30 PDC INSERTION IN THE OPERATING THEATRE (BONNET, SURGICAL GOWN, FACE MASK, STERILE GLOVES, DISINFECTION, STERILE DRAPE) TO RELIEVE LABOUR PAIN - DIFFICULT CONDITIONS - PATIENT WITH ADIP PM 165 CM WITH 125 KG - SPINE PRACTICALLY IMPALPABLE. PUNCTURE AFTER LOCAL ANAESTHESIA, LOSS OF RESISTANCE AT 4.5 CM (TUHOY NEEDLE G 18) CATH. G 20 EASY TO ADVANCE. AT APPROX. 5 CM [?]EPIDURAL' POSITION SAMPLE - INJECTION NOT POSSIBLE - OCCLUSION (TUHOY NEEDLE STILL IN PLACE) - REMOVAL OF TUHOY NEEDLE AND CATHETER TOGETHER WITHOUT CATHETER INSERTION INTO THE NEEDLE; BRIEF RESISTANCE AT THE CATHETER AFTER 1 CM - PULL, THEN NEEDLE AND CATHETER CAN BE PULLED OUT COMPLETELY. DURING THE EPIDURAL CATHETER CHECK, IT IS NOTICED THAT ABOUT 7 CM OF THE DISTAL CATHETER IS MISSING. AS THERE IS STILL SEVERE LABOUR PAIN, A NEW PUNCTURE IS PERFORMED AT THE SAME LEVEL, LATERALLY OFFSET (NEW SET): PROBLEM-FREE PUNCTURE, LOSS OFF RESISTANCE HOWEVER AT 6.5 CM, PROBLEM-FREE PDK INSERTION, GOOD EFFECT UNTIL BIRTH ON (B)(6) 2024 AT 08:00. COMPLETE REMOVAL OF THE 2ND PDC POST PARTUM, PUNCTURE SITES BLANDE. ON (B)(6) 2024, THE PATIENT COMPLAINS OF PRESSURE PAIN IN THE AREA OF THE PUNCTURE SITE IN THE MORNING AND A 'RUBBING SENSATION' WHEN TURNING HER UPPER BODY. CT LUMBAR SPINE: ACCORDING TO RADIOLOGY, A THIN EPIDURAL STRUCTURE IS VISIBLE - APPROX. 9 CM IN LENGTH - AT THE LEVEL OF LWK 2 TO BWK 12, OTHERWISE NO PATHOLOGICAL FINDINGS IN THIS AREA. THE PATIENT'S COMPLAINTS DISAPPEAR COMPLETELY BY (B)(6) 2024 IN THE MORNING. THE PDK WAS PERFORMED BY THE ANAESTHESIOLOGICAL NIGHT SERVICE (OA). PLEASE DESCRIBE THE SERIOUS CONSEQUENCES: FOREIGN BODIES IN THE EPIDURAL SPACE, INFECTIONS, NERVE IRRITATION WITH EFFECTS ON THE LOWER SPINAL NERVE BUNDLES (RADIATION TO THE BUTTOCKS AND LEGS, PAIN, EVEN PARALYSIS POSSIBLE. IMPORTANT: NO SYMPTOMS AT PRESENT, TRIGGERED SYMPTOMS MAY STILL BE COMPLETELY ABSENT.