BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS 21X1-1/2 DN EMERALD

    MDR report key: 11731242 · Received April 27, 2021

    Report

    Report Number
    3002682307-2021-00155
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    December 17, 2020
    Report Date
    June 14, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1904193. 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 UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT OR FOREIGN MATTER WERE IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSPARENT FOREIGN MATTER WAS FOUND IN THE SYRINGE 10ML LS 21X1-1/2 DN EMERALD WHEN DRAWING UP SODIUM CHLORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE USED A 10ML SYRINGE AND OPENED THE OUTER PACKAGE ON (B)(6) 2020. A TRANSPARENT OBJECT WAS FOUND IN THE SYRINGE WHEN INHALING 0.9% SODIUM CHLORIDE INJECTION, SO THE SYRINGE WAS STOPPED IMMEDIATELY. BEFORE OPENING THE OUTER PACKAGE, THE NURSE CHECKED THAT THE OUTER PACKAGE WAS INTACT WITHOUT MOISTURE DAMAGE AND REPLACED ANOTHER SYRINGE."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT TRANSPARENT FOREIGN MATTER WAS FOUND IN THE SYRINGE 10ML LS 21X1-1/2 DN EMERALD WHEN DRAWING UP SODIUM CHLORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NURSE USED A 10ML SYRINGE AND OPENED THE OUTER PACKAGE ON (B)(6) 2020. A TRANSPARENT OBJECT WAS FOUND IN THE SYRINGE WHEN INHALING 0.9% SODIUM CHLORIDE INJECTION, SO THE SYRINGE WAS STOPPED IMMEDIATELY. BEFORE OPENING THE OUTER PACKAGE, THE NURSE CHECKED THAT THE OUTER PACKAGE WAS INTACT WITHOUT MOISTURE DAMAGE AND REPLACED ANOTHER SYRINGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627476 SYRINGE 10ML LS 21X1-1/2 DN EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1904193

    Patients

    Seq Age Sex Outcome Treatment
    1