BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 9250342 · Received October 29, 2019

    Report

    Report Number
    1213809-2019-01074
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS DISPLAYED AN OPENED BLISTER PACK FROM BATCH 4051220 (P/N 305272). TWO PHOTOS DISPLAYED A DISASSEMBLED 3ML INTEGRA SYRINGE WITH THE METAL CUTTER EXPOSED. FROM THE PHOTOS PROVIDED IT CANNOT BE DETERMINED WHEN THE RETRACTION MECHANISM WAS ACTIVATED. ADDITIONALLY, THIS BATCH WAS EXPIRED AS OF 2/28/2019. THE REPORTED DEFECT COULD NOT BE CONFIRMED FROM THE EVIDENCE PROVIDED. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A PIECE OF METAL WAS DISCOVERED IN PLUNGER AND PIERCED THE STOPPER RESULTING IN MEDICATION LEAKING OUT THE BACK WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED THAT A METAL PIECE IN THE PLUNGER PIERCED THE STOPPER RESULTING IN THE MEDICATION LEAKING OUT OF THE BACK OF THE SYRINGE.

    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 DURING USE, A PIECE OF METAL WAS DISCOVERED IN PLUNGER AND PIERCED THE STOPPER RESULTING IN MEDICATION LEAKING OUT THE BACK WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT A METAL PIECE IN THE PLUNGER PIERCED THE STOPPER RESULTING IN THE MEDICATION LEAKING OUT OF THE BACK OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048183 BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 4051220 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other