BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE

    MDR report key: 5124217 · Received October 2, 2015

    Report

    Report Number
    1911916-2015-00002
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 24, 2015
    Report Date
    November 2, 2015
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC ANALYSIS REVEALED THAT THE CANNULA WAS BROKEN AT THE EPOXY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES FOR THE REPORTED LOT NUMBER 4180513. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER NOTES THAT THE CANNULA APPEARS TO HAVE BEEN EXCESSIVELY BENT, POSSIBLY CAUSING THE BREAK.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD GENERAL USE STERILE HYPODERMIC NEEDLE FOR AN INJECTION, THE NEEDLE DETACHED FROM THE NEEDLE HUB AND REMAINED IN THE PATIENT. THE PATIENT RECEIVED AN X-RAY, THE NEEDLE WAS REMOVED WITH FORCEPS, AND THE PATIENT RECEIVED A CT SCAN TO CONFIRM THAT THE NEEDLE WAS REMOVED. THE PATIENT WAS ALSO MONITORED IN THE HOSPITAL'S SHORT STAY SURGERY DEPARTMENT FOR FOUR HOURS AND RECEIVED MULTIPLE PAIN MEDICATIONS. THERE WAS NO REPORT OF INJURY, BLOOD EXPOSURE, OR MEDICAL INTERVENTIONS TO THE CLINICIAN WHO GAVE THE PATIENT THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653548 BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 4180513

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention