BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6109888 · Received November 17, 2016

    Report

    Report Number
    1213809-2016-00043
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 28, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR EVALUATION. THE REPORTED LOT 1220078 WAS MANUFACTURED 08/27/2011 TO 08/30/2011. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO ISSUES RELATED TO THE DEFECT. A QUALITY NOTIFICATION REVIEW INDICATES NO QUALITY NOTIFICATIONS WERE GENERATED. THIS LOT WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ONE WEEK INTO HIS ESTROGEN INJECTIONS AND HAD AN OCCURRENCE OF THE SUSPECT DEVICE FAILING TO RETRACT FOLLOWING USE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762257 22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 1220078

    Patients

    Seq Age Sex Outcome Treatment
    1 Other