BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16427774 · Received February 23, 2023

    Report

    Report Number
    1911916-2023-00096
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 31, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE CRACKED AND STARTED TO LEAK. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGE BARREL HAS A CRACK ABOUT 1" LONG THAT STARTS AT THE 5ML GRADUATION MARK AND ENDS AT THE 13ML GRADUATION MARK. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 2210078. 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 RAILS AND CONVEYORS WERE INSPECTED. NO PINCH POINTS OR MISALIGNMENTS WERE OBSERVED. 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 REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS 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¿ TIP SYRINGE CRACKED WHEN ADMINISTERING MEDICINE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE WAS ADMINISTERING A PRE-FILLED 30 ML SYRINGE WITH ANTIBIOTICS TO A PATIENT VIA IV DIRECT. AFTER APPROX. 8ML OF THE MEDICATION WAS ADMINISTERED, THE NURSE HEARD AN AUDIBLE CRACK, AND NOTICED THAT THE SYRINGE SHE WAS ADMINISTERING THE MEDICATION WITH HAD CRACKED AND STARTED TO LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445054 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210078 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown