BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 13156607 · Received January 4, 2022

    Report

    Report Number
    1911916-2021-01310
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 6, 2021
    Report Date
    January 6, 2022
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : IT WAS REPORTED THERE IS FLUID LEAKING FROM THE BACK OF THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IT IS A 50ML SYRINGE IN A PLASTIC CONTAINER. THE SYRINGE IS BROKEN INTO MULTIPLE PIECES AND IT IS NOT POSSIBLE TO PERFORM ANY ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112012. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROPOFOL LEAKED PAST THE BD LUER-LOK¿ TIP SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THERE IS FLUID LEAKING FROM THE BACK OF THE PLUNGER. IT CONCERNS ARTICLE INJECTION EUROJEC LL 50ML , ARTICLE NUMBER 309653 WITH LOT NUMBER 1112012." "THE BACK OF THE PESTLE LEAKS OUT THE FLUID (PROPOFOL). SO THERE IS A HIGH RISK OF SHALLOW ANAESTHESIA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROPOFOL LEAKED PAST THE BD LUER-LOK¿ TIP SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THERE IS FLUID LEAKING FROM THE BACK OF THE PLUNGER. IT CONCERNS ARTICLE INJECTION EUROJEC LL 50ML , ARTICLE NUMBER 309653 WITH LOT NUMBER 1112012." "THE BACK OF THE PESTLE LEAKS OUT THE FLUID (PROPOFOL). SO THERE IS A HIGH RISK OF SHALLOW ANAESTHESIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269303 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1112012 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown