BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX

    MDR report key: 9849387 · Received March 18, 2020

    Report

    Report Number
    9610825-2020-00062
    Event Type
    Injury
    Date Received
    March 18, 2020
    Report Date
    March 18, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    BSO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR THE BATCH NO. 18D16G8F01, NO ABNORMALITIES OBSERVED DURING THE IN-PROCESS AND FINAL CONTROL INSPECTION. AS NO SAMPLE AND NO PICTURE WAS PROVIDED, PROPER INVESTIGATION ON MALFUNCTION WAS NOT POSSIBLE. HENCE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN: (B)(4). EPIDURAL INSERTION DONE AT L3/L4 LEVEL. CATHETER ADVANCED WITHOUT DIFFICULTY. NEEDLE PULLED OUT WITHOUT DIFFICULTY. FOLLOWING WHICH, THE CATHETER HAD TO BE ADJUSTED (PULLED OUT) TO LEVEL 9CM MARKING AND IT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312152 PERIFIX CATHETER, CONDUCTION, ANESTHETIC BSO B. BRAUN MELSUNGEN AG 18D16G8F0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention