BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7245422 · Received February 6, 2018

    Report

    Report Number
    1213809-2018-00032
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 18, 2018
    Report Date
    March 21, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 13 SAMPLES FROM P/N 305269 WERE RECEIVED; 9 SAMPLES FROM LOT 7121739, 3 SAMPLES FROM LOT 7001875 AND 1 SAMPLE FROM UNKNOWN LOT. SAMPLES FROM LOT 7121739 AND 7001875 WERE INTACT; SYRINGES WITH SEALED PACKAGES. THE ONE SAMPLE FROM LOT 7121739 WAS RECEIVED WITH NO PACKAGE. THE UNPACKAGED SAMPLE WAS VISUALLY EVALUATED AND NO DEFECTS WERE FOUND AROUND THE NEEDLE HUB AREA, THE SYRINGE WAS USED SINCE THE SAFETY MECHANISM WAS ACTIVATED. LEAKAGE CANNOT BE CONFIRMED IN USED/ACTIVATED PRODUCTS. THE OTHER 12 SAMPLES WERE VISUALLY EVALUATED; NO DEFECTS WERE OBSERVED IN THE STOPPER AND NEEDLE HUB AREA. PRODUCT DEFECTS WERE NOT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. (B)(4). NO QUALITY NOTIFICATIONS WERE CREATED FOR ANY OF THE LOTS INVOLVED WITH THIS COMPLAINT. LOT 7121739 AND 7001875 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR LOT 7001875 AND 7121739 WERE VERIFIED, ONLY THIS COMPLAINT HAS BEEN RECEIVED FOR THE LOTS IN QUESTION. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE IS UNKNOWN SINCE NO PRODUCT DEFECTS WERE VISUALLY CONFIRMED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7001875; MEDICAL DEVICE EXPIRATION DATE: 2021-12-31; DEVICE MANUFACTURE DATE: 2017-01-01. MEDICAL DEVICE LOT #: 7121739; MEDICAL DEVICE EXPIRATION DATE: 2022-04-30; DEVICE MANUFACTURE DATE: 2017-05-01; 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

    THE FOLLOWING FIELD HAS BEEN CORRECTED: TYPE OF DEVICE: CORRECTED FROM FMF TO MEG.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS LEAKAGE AT THE HUB ON ONE OF THE DEVICES. THE VACCINE LEAKED FROM THE PLUNGER ON THE OTHER DEVICE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89748 BD INTEGRA¿SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other