BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 21383778 · Received February 14, 2025

    Report

    Report Number
    9610825-2025-00029
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 14, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    OGE
    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. 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.

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126197 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B BRAUN MELSUNGEN AG 4514017C 24K16A8701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown