BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE

    MDR report key: 3170066 · Received April 25, 2013

    Report

    Report Number
    2243072-2013-00040
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPEN 31G X 8MM PEN NEEDLE SAMPLE WAS RETURNED. A 10X VISUAL INSPECTION FOUND BROKEN NEEDLE. EVIDENCE OF RESIDUAL BENDING INDICATING THAT THE NEEDLE WAS BENT AT POINT OF BREAKAGE. NO EVIDENCE OF MANUFACTURING RELATED ISSUES OBSERVED ON THE RETURNED SAMPLE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON-CONFORMANCES WERE RAISED IN ASSOCIATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE NEEDLE BROKE OFF DURING INJECTION IN THE ABDOMEN. PATIENT WENT TO THE HOSPITAL. ABDOMEN WAS X-RAYED. NO NEEDLE COULD BE FOUND. THE NEEDLE REMAINS IN THE ABDOMEN. NO SURGICAL TREATMENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181245 BD PEN NEEDLE 31 G X 8 MM BD PEN NEEDLE FMI BECTON DICKINSON 2247231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention