BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 4491344 · Received February 2, 2015

    Report

    Report Number
    2243072-2015-00014
    Event Type
    Injury
    Date Received
    February 2, 2015
    Date of Event
    January 9, 2015
    Report Date
    February 2, 2015
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TEN UNUSED, REPRESENTATIVE UNITS WERE RECEIVED FOR EVALUATION FROM REPORTED LOT NUMBER 3042143. VISUAL INSPECTIONS OF THE RETURNED UNITS REVEALED NO BENDS, BREAKS, OR DETACHED NEEDLES IN ANY OF THE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 3042143. CONCLUSIONS. A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED AS THE RETURNED UNITS MET MANUFACTURING STANDARDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INJECTING HIMSELF WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, THE CONSUMER HAD THE NEEDLE BREAK OFF IN HIS ARM. THE CONSUMER WENT TO AN EMERGENCY DEPARTMENT WHERE HE WAS EVALUATED AND HAD AN X-RAY. HE WAS REFERRED TO A SURGEON WHO EVALUATED HIM AND THE CONSUMER THEN HAD SURGERY ON (B)(6) 2015. THE SURGEON WAS UNABLE TO REMOVE THE NEEDLE DURING THE SURGERY AND THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH THE SURGEON AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73666 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE WITH NEEDLE FMI BD 3042143

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention