BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE STERILE HYPODERMIC NEEDLE

    MDR report key: 4860055 · Received June 16, 2015

    Report

    Report Number
    2243072-2015-00104
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 16, 2015
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD AND QUAL NOTIFICATION REVEALED NO IRREGULARITIES DURING THE MFR OF THE REPORTED LOT NUMBER 4122684. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD PRECISIONGLIDE SPECIALTY USE STERILE HYPODERMIC NEEDLE FOR AN INJECTION, THE NEEDLE BROKE OFF IN THE PT'S MUSCLE AT THE INJECTION SITE. THE PT REC'D AN X-RAY AND THE BROKEN NEEDLE WAS REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392889 BD PRECISIONGLIDE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD 4122684

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention