BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 22X1-1/4 DN EMERALD

    MDR report key: 9589879 · Received January 15, 2020

    Report

    Report Number
    3002682307-2020-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    October 22, 2019
    Report Date
    February 13, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 30774319 LOT 1811360 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 22X1-1/4 DN EMERALD EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE CRACKS ON THE TUBE, SO IT COULDN'T ABSORB THE DRUG.

    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 THE SYRINGE 5ML LS 22X1-1/4 DN EMERALD EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE CRACKS ON THE TUBE, SO IT COULDN'T ABSORB THE DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57340 SYRINGE 5ML LS 22X1-1/4 DN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1811360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other