BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12253935 · Received July 30, 2021

    Report

    Report Number
    1911916-2021-00764
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SYRINGES ARE LEAKING WHEN DRAWING MEDICATION. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE CAME WITH A YELLOWISH SUBSTANCE. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND NO DEFECTS, IMPERFECTIONS OR LEAKAGE WAS OBSERVED. DUE TO CONTAMINATION, IT NOT POSSIBLE TO TEST FURTHER FOR LEAKAGE. IN THE PHOTOS PROVIDED, ONE PHOTO SHOWS A SYRINGE THAT IS UPSIDE DOWN. IT HAS A YELLOWISH SUBSTANCE AND DROPLETS OF THIS SUBSTANCE PAST THE STOPPER. THE OTHER PHOTO SHOWS A PACKAGING BLISTER TOP WEB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1091421. 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 BD LUER-LOK¿ TIP SYRINGE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE HAD A FEW LEAKAGE COMPLAINTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152193 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1091421 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1