BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA SYRINGE W/DETACHABLE NEEDLE

    MDR report key: 5007800 · Received August 12, 2015

    Report

    Report Number
    1213809-2015-00005
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 28, 2015
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDITIONAL INFORMATION: THE CONSUMER'S SPOUSE ALSO STATED THAT AN ADDITIONAL NEEDLE FROM THE SAME BOX BROKE OFF IN THE MEDICATION VIAL WHILE DRAWING UP THE MEDICATION. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 3234438. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. NOT EVALUATED. REASON: DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A CONSUMER'S WIFE WAS USING A BD INTEGRA 3ML SYRINGE W/DETACHABLE NEEDLE TO INJECT TESTOSTERONE INTO THE CONSUMER'S BUTTOCKS, THE NEEDLE BROKE OFF AND REMAINED IN THE INJECTION SITE & THE CONSUMER'S BEGAN TO BLEED. THE CONSUMER WAS EVALUATED BY A PHYSICIAN AND RECEIVED AN ULTRASOUND WHICH CONFIRMED THAT THE NEEDLE REMAINED IN THE CONSUMER'S INJECTION SITE. NO ADD'L INFO WAS PROVIDED REGARDING ANY ADD'L MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A CONSUMER'S WIFE WAS USING A BD INTREGRA 3ML SYRINGE WITH DETACHABLE NEEDLE TO INJECT TESTOSTERONE INTO THE CONSUMER'S BUTTOCKS, THE NEEDLE BROKE OFF AND REMAINED IN THE INJECTION SITE AND THE CONSUMER BEGAN TO BLEED. THE CONSUMER WAS EVALUATED BY A PHYSICIAN AND RECEIVED AND ULTRASOUND WHICH CONFIRMED THAT THE NEEDLE REMAINED IN THE CONSUMER'S INJECTION SITE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING ANY ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531964 BD INTEGRA SYRINGE W/DETACHABLE NEEDLE HYPODERMIC SYRINGE AND NEEDLE MEG BD MEDICAL SYSTEMS 3234438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention