BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16034689 · Received December 22, 2022

    Report

    Report Number
    1911916-2022-00770
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 2, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A DEEP SCRATCH IN THE SYRINGE AND SOME OF THE SCALE MARKINGS WERE ERASED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL HAS A 2" LONG SCRATCH AT THE TOP PART OF THE BARREL. THERE IS ALSO AN ACCEPTABLE IMPERFECTION IN THE SCALE MARKING. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS INDUCING THE SCRATCH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2033244. 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 PROCESS WAS PERFORMED. THE ALIGNMENT OF THE RAILS AND CONVEYORS WAS CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM DAMAGE 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 · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML SCALES WERE ERASED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH: ALONG WITH THAT, SOME OF THE CAPACITY SCALES WERE ERASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879786 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2033244 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown