BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML

    MDR report key: 15920948 · Received December 5, 2022

    Report

    Report Number
    1911916-2022-00699
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 8, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    50382903096539
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 17-JAN-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED SYRINGES HAVE ODD WHITE MARKING OR PARTICLES IN THE BARREL. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGE BARREL HAS TO RED CIRCLES HIGHLIGHTING A WHITE SPECK, IDENTIFIED AS EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. 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. THE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2179897. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO MITIGATE THE ESCAPE OF THIS DEFECT, THE FREQUENCY OF INSPECTIONS WERE INCREASED. 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 THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML EXPERIENCED ODD WHITE MARKINGS/PARTICLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE WE HAVE OTHER SYRINGES WITH THESE ODD WHITE MARKINGS/PARTICLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML EXPERIENCED ODD WHITE MARKINGS/PARTICLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE WE HAVE OTHER SYRINGES WITH THESE ODD WHITE MARKINGS/PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471442 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2179897 50382903096539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown