BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16010902 · Received December 19, 2022

    Report

    Report Number
    1911916-2022-00762
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 26, 2022
    Report Date
    December 2, 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
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A HAIR FIBER INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND FULL OF A TRANSPARENT SOLUTION. A DARK COLOR STRING OR FIBER CAN BE OBSERVED IN THE SYRINGE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2243285. 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, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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 HAS HAIR FIBER INSIDE THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAIR FIBER LOCATED INSIDE THE BARREL OF A STERILE 50 ML LUER-LOK SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544282 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243285 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown