BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE PEN NEEDLE

    MDR report key: 3010967 · Received March 15, 2013

    Report

    Report Number
    1920898-2013-00003
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 25, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BROKEN CANNULA. MICROSCOPE EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BLEEDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE ADHESIVE MADE THIS OBSERVATION MORE APPARENT. THE SHIELD WAS ALSO EXAMINED FOR ANY POSSIBLE SCRAPES OR CUTS RELATED BY CANNULA RECAPPING OR IMPROPER SHIELDING, HOWEVER NOTHING WAS OBSERVED. THIS COMPLAINT IS NOT CONFIRMED BASED ON THE RESULTS ACHIEVED FROM THE RETURNED SAMPLES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE CONSUMER REPORTED VIA TELEPHONE THAT THE NEEDLE BROKE OFF IN THE STOMACH AND WENT TO THE EMERGENCY ROOM. THEY PERFORMED AN X-RAY AND AFTER REMOVAL OF THE NEEDLE HAD TWO STITCHES PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110306 BD ULTRA FINE PEN NEEDLE 30G PEN NEEDLE FMI BD 2226203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention