BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BNS

    MDR report key: 12260582 · Received August 2, 2021

    Report

    Report Number
    1911916-2021-00773
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    June 2, 2021
    Report Date
    July 27, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT SYRINGES WERE FOUND WITH BLACK AND WHITE DOTS AND DAMAGED OR BROKEN. TO AID IN THE INVESTIGATION, TEN SAMPLES AND EIGHT PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME BULK PACKAGED. A VISUAL INSPECTION WAS PERFORMED AND DAMAGED SYRINGE BARRELS AND EMBEDDED DEGRADED RESIN WAS OBSERVED. THE EIGHT PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT NUMBER 1091338. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY EQUIPMENT WAS PERFORMED. ALIGNMENT OR THE RAILS AND CONVEYORS WERE ACCEPTABLE. FLOW OF PRODUCTS WAS GOOD. FREQUENCY OF INSPECTIONS WERE INCREASED TO MITIGATE THE EMBEDDED DEGRADED RESIN ESCAPES. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: 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. FOR THE DAMAGED PARTS DEFECT, IT IS LIKELY THAT A JAM OCCURRED DURING THE ASSEMBLY PROCESS RESULTING IN THE DAMAGE TO THE SYRINGES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL BNS WAS DAMAGED. THIS OCCURRED ON 65 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGES FOUND WITH BLACK AND WHITE DOT AND DAMAGED/BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159122 SYRINGE 50ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1091338

    Patients

    Seq Age Sex Outcome Treatment
    1