BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7165364 · Received January 4, 2018

    Report

    Report Number
    1213809-2017-00423
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 13, 2017
    Report Date
    March 9, 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
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: ONE LOOSE 3ML INTEGRA ASSEMBLED SYRINGE WITH NEEDLE WAS RECEIVED BY BD (B)(4) AND REPORTED TO BE FROM BATCH #4202864. THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS NOT ACTIVATED AND THE STOPPER WAS IDENTIFIED TO BE FROM MOLD C-249 CAVITY 26. THE STOPPER APPEARS TO HAVE BEEN CUT IN FOUR LOCATIONS BY THE CUTTER. THESE CUTS IN THE STOPPER APPEAR TO BE ALL THE WAY THROUGH THE STOPPER WHICH WOULD RESULT IN LEAKAGE. DHR REVIEW FOR BATCH 4202864: MANUFACTURING DATE: 8/03/2014 TO 08/06/2014. BATCH QUANTITY WAS 360,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4202864 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10115 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 4202864 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other