BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL S/C 48

    MDR report key: 12905803 · Received November 30, 2021

    Report

    Report Number
    1911916-2021-01193
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE ARE FOREIGN SUBSTANCES ON THE SYRINGE TIP. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH EMBEDDED DEGRADED RESIN TOWARDS THE BOTTOM PART OF THE SYRINGE BARREL. NO OTHER DEFECTS OR IMPERFECTIONS ARE 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1113440. 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 THE EMBEDDED DEGRADED RESIN DEFECT, THE FREQUENCY OF INSPECTIONS WERE INCREASED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL S/C 48, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH WITHIN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FOREIGN SUBSTANCES IN SYR. TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 20ML LL S/C 48, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH WITHIN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FOREIGN SUBSTANCES IN SYR. TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800821 BD SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1113440 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown