BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 21167786 · Received January 16, 2025

    Report

    Report Number
    9610825-2024-01024
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 16, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    OGE
    UDI-DI
    04046964558795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. WE RECEIVED ONE USED PERIFIX ONE Ø0,84MM (20G) 80MM P OUT OF ONE PERIFIX ONE 401 FILTERSET IN OPEN PACKAGING. 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: AT THE USED PERIFIX ONE Ø0,84MM (20G) 80MM P THE PART WITH THE CATHETER TIP IS CUT OFF. THE CUT OFF AREA SHOWS A SMOOTH STRUCTURE (SEE PICTURE). THE CUT OFF PART WAS NOT HANDED OVER BY THE CUSTOMER. THE SURFACE OF THE CUT LEADS TO THE ASSUMPTION THAT THIS DAMAGE WAS CAUSED BY A SHARP OBJECT DURING THE APPLICATION PROCESS. THE DAMAGED AREA AT THE CATHETER IS SLANTED AND 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 NOTE: SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF.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 OUTSIDE DIAMETER AND THE LENGTH OF THE PERIFIX ONE Ø0 ,84MM (20G) 80MM P WERE MEASURED ACCORDING DRAWING. OUTSIDE DIAMETER: NOMINAL: 0.84 MM +-0.04 MM ACTUAL: BETWEEN 0.82 MM AND 0.83 MM. LENGTH OF THE CATHETER: NOMINAL: 1010 MM +- 7.5 MM ACTUAL: APPROX. 950 MM 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 AND THEREFORE, WE CONSIDER THE COMPLAINT AS NOT CONFIRMED. BASED ON THE CONDUCTED INVESTIGATIONS THE CHECKED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2024 AT 5PM THERE WAS AN ATTEMPT TO PERFORM AN EPIDURAL INSERTION. THE FIRST ATTEMPT BY INTERN FAILS. THERE WAS A SUCCESSFUL INSERTION ON SECOND ATTEMPT BY SENIOR ANESTHETIST. REPORTEDLY THE EPIDURAL DOES NOT WORK. AT 7PM A SECOND EPIDURAL WAS INSERTED AFTER REMOVAL OF FIRST EPIDURAL CATHETER; A PIECE OF KT (APPROXIMATELY 7 TO 8 CENTIMETERS) IS MISSING. CHECKED BY CT SCAN THE NEXT DAY: THE KT IS IN THE PATIENT'S BACK. PATIENT INFORMED - NO PARTICULAR PAIN BUT PSYCHOLOGICAL SHOCK. DECISION TO LEAVE THE KT IN PLACE. AN ULTRASOUND PROJECT IS PLANNED IN 1 MONTH TO VERIFY THE APPEARANCE OF A GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509285 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B BRAUN MELSUNGEN AG 4514017C 24H20A8701 04046964558795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown