BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8169760 · Received December 17, 2018

    Report

    Report Number
    1213809-2018-00887
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 30, 2018
    Report Date
    February 1, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A USED CONTAMINATED INTEGRA SYRINGE IN AN OPENED PACKAGE FROM BATCH #7121739 (P/N ARRIVED WRAPPED IN BROWN PAPER INSIDE AN ENVELOPE. A HAND WRITTEN NOTE WAS FOUND THAT READ ¿REFERENCE 68352.¿ THE NEEDLE WAS OBSERVED RETRACTED WITH NO SIGNS OF LEAKAGE IN THE PACKAGE. SINCE THE SAMPLE WAS USED AND CONTAMINATED IT COULD NOT BE FURTHER EVALUATED. NO UNUSED REPRESENTATIVE SAMPLES FROM THE COMPLAINT LOT AND/OR CARTON WERE RECEIVED FOR EVALUATION AND TESTING. THEREFORE THE DEFECT COULD NOT BE CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE HAD LEAKAGE FROM THE HUB.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE HAD LEAKAGE FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010819 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 6267658 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other