BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 7073490 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00336
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 6, 2017
    Report Date
    March 20, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH 7190529 (P/N 309649): MANUFACTURING DATES: 07/10/2017 TO 07/11/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7190529 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: TWO OPEN 5ML PACKAGED SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7190529 (P/N 309649). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MISSING PRINT. THE PRINT WAS ALMOST ENTIRELY MISSING FROM THE BARREL. MISSING PRINT AS OBSERVED IN THESE SAMPLES PROVIDED IS A REJECTABLE CONDITION AT BD CANAAN. BASED ON SAMPLE, THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. MACHINE LOGS INDICATE AN INSTANCE OF BARRELS WITHOUT PRINT WAS RECORDED DURING MANUFACTURE OF THIS BATCH AND SEVERAL INSTANCES OF MARKER DOWN TIME. POTENTIAL ROOT CAUSE: THE MOST LIKELY ROOT CAUSE IS INSUFFICIENT INK PRESENCE ON THE PAD AFTER MARKER START UP AND FAILURE TO DISCARD INITIAL START UP BARRELS. INVESTIGATION CONCLUSION: THE MOST LIKELY ROOT CAUSE IS INSUFFICIENT INK PRESENCE ON THE PAD AFTER MARKER START UP AND FAILURE TO DISCARD INITIAL START UP BARRELS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ LUER-LOK¿ SYRINGE WAS MISSING THE NUMERIC INCREMENTS. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852305 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7190529 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other