BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12724955 · Received October 30, 2021

    Report

    Report Number
    1911916-2021-01127
    Event Type
    Malfunction
    Date Received
    October 30, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WAS A HAIR WAS FOUND IN OR ON THE PRODUCT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER AND FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND A FINE FIBER THAT LOOKED LIKE HAIR WAS OBSERVED INSIDE AND ADHERED TO THE TOP AND BOTTOM WEBS OF THE SEALING ARE OF THE PACKAGING BLISTER. WHEN THE PACKAGING BLISTER WAS OPENED AND THE SYRINGE WAS REMOVED THE FIBER LIKE HAIR FEEL AND WAS LOST. NO ADDITIONAL TESTING COULD BE PERFORMED. THE FOUR PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR IF AN ASSOCIATE WAS NOT GOWNED PROPERLY INDUCING THE SYMPTOM REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 9120857. 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 GOWNING OF ASSOCIATES WAS PERFORMED FINDING THEM ALL PROPERLY GOWNED. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS AN OPEN UNIT PACKAGE/SEAL WHERE STERILITY OF THE PRODUCT IS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "HAIR WAS FOUND IN/ON THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623118 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9120857 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1