BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 2397183 · Received December 27, 2011

    Report

    Report Number
    1911916-2011-00012
    Event Type
    Injury
    Date Received
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A BULK, NON-STERILE DISPOSABLE HYPODERMIC NEEDLE INCLUDED IN AN UNSPECIFIED B BRAUN KIT, SPECIFIC NEEDLE CATALOG AND LOT NUMBER ARE NOT KNOWN BUT ARE BELIEVED TO BE EITHER CATALOG 301658, 27G X 1 1/4", LOT 25G 0321242 OR CATALOG 303010 25G X 5/8" LOT 0183336, OR 0210958. NO ADD'L INFO INVOLVING THE EVENT IS AVAILABLE.

    Description of Event or Problem · 1

    LABOR AND DELIVERY PT - EITHER 25 OR 27 GAUGE SKIN WHEAL NEEDLE BROKE OFF WHILE PERFORMING THE SKIN WHEAL, REQUIRING INCISION TO RETRIEVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PRECISIONGLIDE NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention