BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7237392 · Received February 2, 2018

    Report

    Report Number
    1213809-2018-00017
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    December 11, 2017
    Report Date
    February 22, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLE EVALUATION: ONE LOOSE 1ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7082993 (P/N 309628). THE SAMPLE WAS VISUALLY EVALUATED. THE BARREL WAS CONFIRMED TO BE FROM MOLD # L-78, CAVITY #13. THE SAMPLE APPEARED TO HAVE BEEN CUT REMOVING THE TOP PORTION OF THE BARREL PRIOR TO BEING SENT TO BD. THE BARREL WAS FOUND TO HAVE EMBEDDED FOREIGN MATTER. THE FM WAS SMALL BLACK DOTS THROUGHOUT THE ENTIRETY OF THE BARREL. THE SAMPLE ALSO HAS SCUFFS / MARKS ON THE BARREL NEAR THE 0.2 GRADLINE, IT WAS NOT CLEAR IF THIS WAS CAUSED FROM THE BARREL BEING CUT OR WAS PRESENT PRIOR TO THAT. DHR REVIEW FOR BATCH 7082993 (P/N 309628): MANUFACTURING DATES: 04/04/2017 ¿ 04/05/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. A WATER LEAK WAS RECORDED IN ONE OF THE MOLDING MACHINES MANUFACTURING THE BARRELS FOR THIS PRODUCT. THE MACHINE WAS DOWN FOR APPROXIMATELY 4 HOURS TO ADDRESS THE PROBLEM BEFORE PRODUCTION RESUMED. BATCH 7082993 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE: THE DEFECT OBSERVED WAS IDENTIFIED AS OVER PROCESSED PLASTIC DUE TO ELEVATED TEMPERATURE INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. IT IS POSSIBLE THAT SOME OF THE DEGRADED PLASTIC REMAINS INSIDE THE MOLDS MANIFOLD AND MAY BECOME DISLODGED AFFECTING A LIMITED NUMBER OF BARRELS. THIS CONDITION IS ATTRIBUTED IN PART TO THE INCONSISTENT FREQUENCY OF MOLD MANIFOLD CLEANING. THE OVERALL DEFECTIVE RATE REMAINS LOW BASED ON THE NUMBER OF COMPLAINTS AND DEFECTIVE PARTS RECEIVED FOR BATCH 7082993. CORRECTIVE ACTIONS: (1) MANIFOLD CLEANING FREQUENCY WAS RECENTLY INCREASED AS A PREVENTIVE MEASURE FOR EMBEDDED FOREIGN MATTER SIMILAR TO THE DEFECT OBSERVED IN THE SAMPLE RECEIVED. THE MOST RECENT MANIFOLD CLEANING FOR THIS MOLD WAS PERFORMED IN JANUARY 2018. (2) THE MANIFOLD CLEANING WAS ADDED TO THE PREVENTIVE MAINTENANCE PLAN OF THE MOLD. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE ORIGINAL "TYPE OF DEVICE" REPORTED IS INCORRECT, AND HAS BEEN CORRECTED TO REFLECT "FMF".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER, DESCRIBED AS ¿BLACK FLECKS¿, WAS FOUND IN A BD LUER-LOK¿ DISPOSABLE SYRINGE(S). THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82944 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7082993 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other