BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G PEN NEEDLE

    MDR report key: 1364663 · Received April 17, 2009

    Report

    Report Number
    9616656-2009-00007
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 17, 2009
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - ISSUE: NEEDLE STICK INJURY. EVALUATION: REGULATORY COMPLIANCE COMPLAINT LAB RECEIVED ONE (1) 31G X 8 MM SEALED PEN NEEDLE (LOT#: 8162516) WHICH CUSTOMER CLAIMS THE NURSE GOT STUCK WITH PRIOR TO RECAPPING PEN NEEDLE. PEN NEEDLE FROM THE REPORTED LOT (8162516) WAS EVALUATED AND REVEALED NO POINT DAMAGE, WAS AMPLY LUBRICATED AND MET SPECIFICATION FOR 31G CANNULA OUTER DIAMETER . CUSTOMER INDICATED RECEIVED NEEDLE STICK INJURY PRIOR TO RECAPPING PEN NEEDLE, IFU STATES "NEVER RECAP". CANNOT CONFIRM COMPLAINT AS A MFG DEFECT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    NURSE SUPERVISOR REPORTED THAT ONE OF THE NURSES WAS USING BD PEN NEEDLE GIVING FORETEO INJECTION TO A PT AND GOT STUCK PRIOR TO RECAPPING PEN NEEDLE. NURSE RECEIVED A TETANUS SHOT AND BLOOD TEST WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND CO. NA 8162516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention