BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE CONTROL 10ML LL BNS

    MDR report key: 9453127 · Received December 11, 2019

    Report

    Report Number
    1213809-2019-01257
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 20, 2019
    Report Date
    January 31, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 10ML CONTROL SYRINGE FILLED WITH CLEAR FLUID AND A NEEDLE ATTACHED WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS NO THUMB RING PRESENT ON THE SYRINGE. THIS IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH #9112830 (P/N 304134): RELEASE DATE: 5/06/2019. RELEASED QUANTITY WAS (B)(4). MOLDING AND ASSEMBLY ORDERS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. MOLDING ISSUE CAUSING THUMBGRIPS TO NOT ATTACH WAS DISCOVERED DURING PRODUCTION. CORRECTIONS WERE MADE AND PRODUCT WAS REQUALIFIED AT MOLDING PER APPLICABLE AQL. BATCH 9112830 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. POTENTIAL ROOT CAUSE: (1) PART STUCK WITHIN MOLDING MACHINE LEADING TO FLASH WHICH PREVENTED IT FROM PROPERLY WELDING DURING PRODUCT¿S ASSEMBLY. A CORRECTIVE ACTIONS PROJECT IS UNDERWAY TO ADDRESS THE ROOT CAUSE. MOLD¿S TOOLING IS BEING MODIFIED TO MITIGATE THE OCCURRENCE OF PARTS BEING STUCK IN THE MOLDING MACHINE. TARGET COMPLETION DATE: 15 APR 2020. COMPLAINTS WILL BE MONITORED FOR 6 MONTHS POST COMPLETION OF THE C/A PROJECT FOR THIS DEFECT TO ASSESS EFFECTIVENESS. NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE PLUNGER FLANGE WAS BROKEN WITH A BD SYRINGE CONTROL 10ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE THUMB PORTION WAS MISSING FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE PLUNGER FLANGE WAS BROKEN WITH A BD SYRINGE CONTROL 10ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE THUMB PORTION WAS MISSING FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250303 BD SYRINGE CONTROL 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9112830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other