BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9489808 · Received December 18, 2019

    Report

    Report Number
    3002682307-2019-00674
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 31, 2019
    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

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 30773319 LOT 1811391 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 22X1-1/4 AN EMERALD EXPERIENCED A CRACKED/DAMAGED/HOLE IN THE NEEDLE HUB THAT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE PREPARED TO ADD THE MEDICINE, OPENED THE PACKAGING OF THE SYRINGE AND FOUND THAT THE END OF THE NEEDLE WAS CRACKED. THE OPERATION CONTINUED AFTER THE REPLACEMENT.

    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 AN EMERALD EXPERIENCED A CRACKED/DAMAGED/HOLE IN THE NEEDLE HUB THAT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE PREPARED TO ADD THE MEDICINE, OPENED THE PACKAGING OF THE SYRINGE AND FOUND THAT THE END OF THE NEEDLE WAS CRACKED. THE OPERATION CONTINUED AFTER THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286637 SYRINGE 5ML LS 22X1-1/4 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1811391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other