BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7818460 · Received August 27, 2018

    Report

    Report Number
    1213809-2018-00573
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 10, 2018
    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
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    18 SEALED PACKAGED INTEGRA SYRINGES WITH NEEDLES WERE RECEIVED, CONFIRMED TO BE FROM BATCH #8002915 (P/N 305270). THEY WERE VISUALLY EVALUATED. ALL SYRINGES HAD CANNULAS ATTACHED AND UNBROKEN. THE CANNULA TIPS APPEARED TO BE SHARP WITH NO DEFECTS OBSERVED. THE SYRINGES WERE THEN EVALUATED FOR NEEDLE RETRACTION. EACH RETRACTION MECHANISM WAS ACTIVATED BY PRESSING ON THE PLUNGER ¿ ALL CANNULAS RETRACTED AS DESIGNED WITH NO ISSUES OBSERVED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD INTEGRA SYRINGE WITH DETACHABLE NEEDLES, THE NEEDLE BROKE AFTER INJECTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AFTER USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLES, THE NEEDLE BROKE AFTER INJECTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662153 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 8002915 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other