BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 3 ML BD LUER-LOK¿ SYRINGE WITH BLUNT FILL NEEDLE

    MDR report key: 7535050 · Received May 22, 2018

    Report

    Report Number
    1213809-2018-00290
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE LOOSE 3ML ASSEMBLED SYRINGE WITH NEEDLE WAS RECEIVED BY BD AND REPORTED TO BE FROM UNKNOWN BATCH#, POSSIBLY 8064738, 8033815, 8011510 (P/N 305060). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE FOREIGN MATTER IN THE SYRINGE FLUID PATH. THE FOREIGN MATTER OBSERVED WAS MADE UP OF A MIXTURE OF WHITE AND BLACK FIBERS. THE FOREIGN MATTER IS LARGER THAN LEVEL 3 IN SIZE WHICH IS A REJECTABLE CONDITION AT BD CANAAN. BASED ON THE EVALUATION PERFORMED, THE DEFECT IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. DHR REVIEW FOR BATCH 8011510 (P/N 305060): MANUFACTURING DATES: 01/13/2018 TO 01/14/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8011510 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 8033815 (P/N 305060): MANUFACTURING DATES: 02/23/2018 TO 02/24/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8033815 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 8064738 (P/N 305060): MANUFACTURING DATES: 03/21/2018 TO 03/22/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8064738 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE 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 A PIECE OF FOREIGN MATTER "PLASTIC OR METAL PIECE" WAS FOUND IN THE BARREL OF A BD¿ 3 ML BD LUER-LOK¿ SYRINGE WITH BLUNT FILL NEEDLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378249 BD¿ 3 ML BD LUER-LOK¿ SYRINGE WITH BLUNT FILL NEEDLE SYRINGE WITH HYPODERMIC NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other