BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 17839434 · Received September 28, 2023

    Report

    Report Number
    1911916-2023-00699
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 13, 2023
    Report Date
    September 15, 2023
    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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED A PIECE OF THE FLANGE WAS INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE IS CONNECTED TO A BOTTLE OF SODIUM CHLORIDE FROM FRESENIUS KABI. INSIDE THE SYRINGE IS A PIECE OF BARREL FLANGE. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE IS A JAM DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 2070232. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF CONVEYORS AND FLOW OF PRODUCT WAS GOOD. 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 A PIECE OF THE FLANGE HAD FALLEN INSIDE THE BD LUER-LOK¿ TIP SYRINGE BARREL AND WAS FOUND AFTER DRAWING UP THE SODIUM CHLORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A 20ML SYRINGE LUER LOK FAULTY REF: 302830 LOT: 2070232. INCIDENT HAPPENED THIS MORNING, WHEN DRAWING UP SODIUM CHLORIDE THE ANAESTHETIST THOUGHT IT WAS AN AIR BUBBLE IN THE BARREL, UPON CLOSER INSPECTION FOUND A PIECE OF THE FLANGE WAS INSIDE THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063353 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2070232 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown