BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 13450740 · Received February 4, 2022

    Report

    Report Number
    1911916-2022-00052
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 14, 2022
    Report Date
    February 3, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE FOURTH SYRINGE ON THE STRIP WASN'T SEALED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1180467. THE REVIEW REVEALED DOCUMENTATION OF THIS TYPE OF DEFECT DURING THE PRODUCTION RUN OF THIS BATCH. AT THE PACKAGING STATION, THE SEAL GASKET WAS FOUND DAMAGED AND IT WAS REPLACED. A NOTIFICATION WAS ISSUED AND THE DEFECTIVE PARTS WERE SEGREGATED, THOUGH IT COULD BE POSSIBLE THESE PRODUCTS ESCAPED DURING THIS ISSUE WHILE PRODUCING THIS BATCH. BASED ON THE INVESTIGATION AND WITH NO RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE 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 PACKAGE SEAL WAS COMPROMISED ON THE BD SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR INVENTORY CONTROL FOUND OUT THAT THIS ITEM WAS MANUFACTURED IN A WAY THAT THE FOURTH SYRINGE ON A STRIP ISN¿T SEALED AND IS THEREFORE NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987323 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1180467 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown