BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL NEEDLE KIT: 17G A X 3-1/2IN (8.89

    MDR report key: 3002343 · Received March 8, 2013

    Report

    Report Number
    1036844-2013-00084
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K770356
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIANS ARE FINDING WHEN KITS ARE OPENED THE 5ML AMPULES HCI 1% LIDOCAINE SOLUTION AND/OR 10ML AMPULE 0.9% SALINE SOLUTION ARE BROKEN OPEN EMPTY IN KITS. IT APPEARS THE AMPULES ARE SLIPPING OUT OF THEIR SLOT IN THE TRAY DURING SHIPPING. THE CLINICIANS ALLEGE THIS HAS OCCURRED SEVERAL TIMES BUT DO NOT HAVE AN EXACT NUMBER. THE KITS WERE USED SUCCESSFULLY USING HOSP MEDS FOR THE PROCEDURES. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT. THERE HAS BEEN NO PT HARM, NO DEATH, AND NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99256 EPIDURAL NEEDLE KIT: 17G A X 3-1/2IN (8.89 ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF2107652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK