BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7059767 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00290
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 29, 2017
    Report Date
    February 6, 2018
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    UDI-DI
    30382903095705
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER AS INDICATED BELOW. MEDICAL DEVICE LOT #: 6117578, MEDICAL DEVICE EXPIRATION DATE: 04/30/2021, DEVICE MANUFACTURE DATE: 04/26/2016. MEDICAL DEVICE LOT #: 6148981, MEDICAL DEVICE EXPIRATION DATE: 04/30/2021, DEVICE MANUFACTURE DATE: 05/27/2016. THE ABOVE LOT NUMBERS WERE ANNOTATED ON THE SUPPLEMENTAL INVESTIGATION REPORT. HOWEVER, A DEVICE HISTORY REVIEW WILL NEED TO BE PERFORMED. ONCE THE INVESTIGATION IS COMPLETE, AN ADDITIONAL SUPPLEMENTAL WILL BE FILED.

    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: SAMPLE EVALUATION: EIGHT 3ML SYRINGES IN OPENED PACKAGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7122596, 6117578 AND 6148981 (P/N 309570). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE A SMALL AMOUNT OF VISIBLE SILICONE IN THE BARREL ON THE STOPPER. THE EXCESSIVE STRINGING OF SILICONE AS DESCRIBED IN THE COMPLAINT DESCRIPTION WAS NOT OBSERVED IN ANY OF THE SAMPLES RECEIVED. THE AMOUNT OF SILICONE OBSERVED WAS A NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 7122596 (P/N 309570): MANUFACTURING DATES: 05/30/2017 TO 05/31/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE WEIGHT TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 7122596 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. CONCLUSION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. NO ABSOLUTE ROOT CAUSE, NO DEFECTS WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL HUNDRED BOXES OF 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLES WERE FOUND WITH SUBSTANCE IN THEM. IT WAS REPORTED THAT AIR POCKETS APPEAR TO BE CREATED WHEN MOVING THE PLUNGER DOWNWARDS AND ¿STRING OF SUBSTANCE¿ IS PULLED DOWN BY THE STOPPER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840664 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10. 30382903095705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other