BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6891904 · Received September 25, 2017

    Report

    Report Number
    1213809-2017-00137
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 31, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    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 · 1

    INVESTIGATION: DHR REVIEW FOR BATCH 6201979 (P/N 305269): MANUFACTURING DATES: 08/12/2016 TO 08/14/2016. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201979 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: TWO LOOSE 3ML ASSEMBLED INTEGRA SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #6201979 (P/N 305269). THE SAMPLES WERE VISUALLY EVALUATED. SYRINGE 1 - SYRINGE IS ACTIVATED BUT PLUNGER ROD IS NOT IN FULL / BOTTOM POSITION. THIS IS EVIDENCE OF ACTIVATION PRIOR TO COMPLETION OF SYRINGE USE. NO LIQUID OR CRACKS WERE OBSERVED ON THE SYRINGE EXTERIOR. THE PREMATURE ACTIVATION CAN HAPPEN IF THE STOPPER ENCOUNTERED SUFFICIENT RESISTANCE DURING USE. SYRINGE 2 - THE SYRINGE APPEARED USED. THE EVALUATION WAS PERFORMED VISUALLY ONLY, FUNCTION AND LEAKAGE WAS NOT TESTED DUE TO THE SYRINGE CONTAINING AN UNIDENTIFIED LIQUID. DURING THE VISUAL EVALUATION A PIECE OF TAPE WAS OBSERVED ATTACHED TO THE BARREL EXTERIOR AND WHAT APPEARS TO BE ADHESIVE IS ON THE BARREL EXTERIOR NEAR THE BARREL THREADS. NO LIQUID OR CRACKS WERE OBSERVED ON THE SYRINGE EXTERIOR. 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. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME. ROOT CAUSE: THE PREMATURE ACTIVATION CAN HAPPEN IF THE STOPPER ENCOUNTERED SUFFICIENT RESISTANCE DURING USE.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICATION LEAKED OUT OF THE SIDES OF THE 25 G X 5/8 IN. BD INTEGRA" 3 ML SYRINGE WITH DETACHABLE NEEDLE, DURING USE. SAFETY IS ALSO ACTIVATING TOO SOON. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670957 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 6201979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other