BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 13584709 · Received February 23, 2022

    Report

    Report Number
    1911916-2022-00096
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 28, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WERE MULTIPLE DEFECTS WITH THE PRODUCTS RECEIVED. TO AID IN THE INVESTIGATION, TEN SAMPLES RECEIVED BULK PACKAGED IN A PLASTIC BAG AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. EIGHT SAMPLES HAVE EMBEDDED DEGRADED RESIN, ONE SAMPLE HAS A DEEP SCUFF MARK ON THE BARREL, AND ONE HAD NO DEFECTS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE FOUR PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBER 1113393. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE FREQUENCY OF INSPECTIONS WERE INCREASED TO HELP MITIGATE THE ESCAPE OF THIS DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ LUER-LOK SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH COMPONENT. THIS EVENT OCCURRED 314 TIMES. THE FOLLOWING INFORMATION WAS: BLACK DOTS: (B)(4) PIECES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ LUER-LOK SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH COMPONENT. THIS EVENT OCCURRED 314 TIMES. THE FOLLOWING INFORMATION WAS: BLACK DOTS: 314 PIECES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929477 BD¿ LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1113393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown