BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPILOR PLASTIC LOR

    MDR report key: 3492095 · Received October 25, 2013

    Report

    Report Number
    2243072-2013-00143
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    September 11, 2013
    Report Date
    October 25, 2013
    Manufacturer
    BD
    Product Code
    FMF
    Removal / Correction Number
    2243072-08-22-13-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT DURING A CERVICAL PAIN INJECTION, THE PLUNGER ON A 7ML EPILOR LOSS OF RESISTANCE SYRINGE WAS STICKING. THE M.D. PERFORMING THE PROCEDURE MET RESISTANCE AND WENT INTO A VESSEL. THE NEEDLE POSITION WAS CHANGED AT THAT TIME, PRESUMABLY AS A RESULT OF THE STICKING PLUNGER. THE M.D. ASPIRATED BLOOD WHICH INDICATED THE VASCULAR POSITION AT THE TIP OF THE NEEDLE. THE PHYSICIAN WITHDRAW THE NEEDLE AND THEN IMMEDIATELY PERFORMED A BLOOD PATCH PROCEDURE TO PREVENT A POST SPINAL OR EPIDURAL ANESTHESIA AND WAS RESCHEDULED FOR ANOTHER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550328 EPILOR PLASTIC LOR SYRINGE FMF BD

    Patients

    Seq Age Sex Outcome Treatment
    1