BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 2ML LS DN EMERALD

    MDR report key: 12833325 · Received November 17, 2021

    Report

    Report Number
    3002682307-2021-00618
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 18, 2021
    Report Date
    January 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011199. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE NOT AVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD THE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE TRIED TO DRAW THE MEDICINE, THE SYRINGE WAS BLOCKED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD THE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE TRIED TO DRAW THE MEDICINE, THE SYRINGE WAS BLOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724130 BD SYRINGE 2ML LS DN EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown