BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 GA PEN NEEDLE

    MDR report key: 922084 · Received October 3, 2007

    Report

    Report Number
    9616656-2007-00015
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    September 5, 2007
    Report Date
    October 3, 2007
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [EVALUATION DATE/TIME: 2006 16:21:18] CONTACT A: COMPLAINT LAB RECEIVED 1 OPENED PEN NEEDLE WITH BROKEN CANNULA. CUSTOMER CLAIMS NEEDLE BROKE OFF AFTER INJECTION IN THE STOMACH. PRODUCT FORWARDED TO WORLD WIDE MICROSCOPY LABORATORY TO INVESTIGATE ROOT CAUSE OF CANNULA BREAK OFF. EVALUATION DATE/TIME: THE FOLLOWING MONTH, 15:35:35] RESPONSE FROM WWML MTR # 4630 FOR CONTACT A: ONE BROKEN PEN NEEDLE WAS RETURNED FOR FAILURE ANALYSIS. MICROSCOPIC EXAMINATION REVEALED CHARACTERISTICS SUCH AS RESIDUAL BEND, TUBING OVALITY AND CRACKED EPOXY, THESE CHARACTERISTICS WHEN VIEWED IN CONTEXT ARE ALL RELIABLE INDICATORS OF BENDING/RESTRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE EPOXY MADE THIS OBSERVATION MORE APPARENT. THE ABSENCE OF ANY OBVIOUS MANUFACTURING RELATED DEFECTS SUGGESTS A USER RELATED ISSUE.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT PEN NEEDLE BROKE OFF IN STOMACH AFTER INJECTION. WENT TO HOSPITAL AND HAD X-RAYS PERFORMED. NEEDLE WAS NOT LOCATED BUT WAS GIVEN CEPHALEXIN. WILL BE GOING TO FAMILY DR. FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31 GA PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 6184471

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R