BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU NEUROLINE TP SUBDERMAL

    MDR report key: 3926098 · Received July 1, 2014

    Report

    Report Number
    9610691-2014-00002
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    AMBU A/S
    Product Code
    IKT
    PMA / PMN Number
    K020907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED TO AMBU BUT PICTURE OF THE BROKEN DEVICE AND LOT INFORMATION PROVIDED FOR TRACEABILITY. THE PICTURE SHOWS THAT THE WIRE IS NO LONGER ATTACHED TO THE HUB OF THE NEEDLE, LEAVING THE NEEDLE IN THE PATIENT TO BE REMOVED BY THE FINGERS BY PULLING THE HUB. THE PRODUCTION RECORDS HAVE BEEN REVIEWED, AND NO DEVIATIONS WERE FOUND. RETENTION SAMPLE HAS BEEN INVESTIGATED: THE RETENTION SAMPLE PASS THE PULL TEST WITH READING 3.89KG AND 3.95KG RESPECTIVELY. THE PULL STRENGTH IS WITHIN SPECIFICATION FOR THIS RETENTION SAMPLE. THE ROOT CAUSE OF THE WIRE SEPARATING FROM THE HUB IS NOT DETERMINABLE. NEITHER IS THE REASON WHY THE USER SUBSEQUENTLY GOT STUCK BY THE NEEDLE.

    Description of Event or Problem · 1

    NEEDLE BROKE FROM WIRE AND NEEDLE WAS LEFT IN PATIENT, WHEN REMOVING THE NEEDLE BY THE FINGERS A FACILITY STAFF PERSON STUCK BY NEEDLE. NO HARM TO PATIENT, BUT PATIENT IS (B)(6). THE FACILITY HAS INFORMED THAT MEDICAL INTERVENTION HAS BEEN TAKEN ON THE STAFFER: "SHE STARTED SIX WEEKS OF CONTINUOUS MEDICATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381609 AMBU NEUROLINE TP SUBDERMAL NEEDLE ELECTRODE IKT AMBU A/S 1562602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other