BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB

    MDR report key: 12236572 · Received July 28, 2021

    Report

    Report Number
    1911916-2021-00734
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903059059
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. MEDICAL DEVICE TYPE: AN ADDITIONAL DEVICE TYPE OF FMI APPLIES TO THIS DEVICE. PMA/510(K)#: AN ADDITIONAL PMA/510(K) OF K951254 APPLIES TO THE DEVICE. INVESTIGATION SUMMARY: IT WAS REPORTED THE TOP OF THE SYRINGE WAS DIRTY. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A 3ML SYRINGE OUT OF THE PACKAGING BLISTER WITH BROWN SPOTS AT THE LUER LOCK. FROM THE PHOTO IT APPEARS TO BE EMBEDDED DEGRADED RESIN. 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 305905, LOT NUMBER 0342777. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. 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 THE SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRTY ON THE TOP OF SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139577 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB PISTON SYRINGE, HYPODERMIC SINGLE LUMEN NEEDLE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 305905 0342777 30382903059059

    Patients

    Seq Age Sex Outcome Treatment
    1