BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE 60 ML

    MDR report key: 11530061 · Received March 19, 2021

    Report

    Report Number
    1911916-2021-00230
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 15, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0274524, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: 2020-09-30, MEDICAL DEVICE LOT #: 0274525, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: 2020-09-30, MEDICAL DEVICE LOT #: 9240673, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035 AND LOT NUMBERS 9240763, 0274524 AND 0274525. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWO OF THE PHOTOS SHOW FOUR SYRINGES WITH EMBEDDED DEGRADED RESIN. THE OTHER PHOTO SHOWS A TORN PLASTIC BAG WITH WHAT APPEARS TO BE AN INSECT. IT COULD BE POSSIBLE FOR THE EMBEDDED DEGRADED RESIN DEFECT TO OCCUR DURING THE MOLDING PROCESS. EMBEDDED DEGRADED RESIN IN THE COMPONENT OCCURS AT THE STARTUP OF AN INJECTION MOLD / PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE HOT-RUNNER SYSTEM, CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. IN REGARDS TO THE PHOTO THAT APPEARS TO BE AN INSECT, THE PROBABLE ROOT CAUSE IS UNKNOWN. THESE SYRINGES ARE A BULK PRODUCT PACKAGED IN PLASTIC BAGS THAT ARE NOT SEALED. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD¿ LUER-LOK SYRINGE 60 ML EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TECHNICIANS WORKING ON THE ASSEMBLY TABLE FOUND SYRINGES WITH BLACK PARTICLES AND INSIDE ONE OF THE BAGS THERE IS A DEAD FLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427712 BD LUER-LOK SYRINGE 60 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1