BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7006991 · Received November 7, 2017

    Report

    Report Number
    1213809-2017-00245
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 12, 2017
    Report Date
    January 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    RESULTS: DHR REVIEW FOR BATCH 7121741 (P/N 305270): MANUFACTURING DATES: 06/05/2017 TO 06/12/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121741 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE USED 3ML INTEGRA SYRINGE WITH AN OPENED PACKAGE WAS RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH 7121741 (P/N 305270). TWO PHOTOS ALSO ACCOMPANIED THE SAMPLE. IN THE PHOTOS, THE STOPPER CAN BE OBSERVED INSECURELY ATTACHED TO THE PLUNGER PRIOR TO THE SYRINGE BEING USED. THE PHYSICAL SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS LABELED WITH A STICKER MENACTRA AND THE PLUNGER/NEEDLE MECHANISM WAS ACTIVATED, INDICATING IT WAS MANIPULATED. THE STOPPER WAS AT THE BOTTOM OF THE BARREL NEAR THE ZERO LINE. THE STOPPER WAS OBSERVED TO STILL BE SLIGHTLY ANGLED BUT MOSTLY CORRECTED AFTER NEEDLE RETRACTION ACTIVATION. CONCLUSION: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ALTHOUGH BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 23 G X 1 IN. BD INTEGRA" 3 ML SYRINGE WITH DETACHABLE NEEDLE THE NEEDLE WAS SLOW IN RETRACTION. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787746 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 7121741 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other