BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYER CABLE 12 FT DISPOSABLE

    MDR report key: 7713996 · Received July 23, 2018

    Report

    Report Number
    MW5078531
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    July 20, 2018
    Report Date
    July 20, 2018
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT PACKAGE WITH TWO EXTRA PINS IN THE PACKET. PINS WERE IN THE RUBBER COVERING AND DISCOVERED PRIOR TO PT EXPOSURE BUT COULD HAVE DROPPED INTO STERILE FIELD. USED IN ELECTROPHYSIOLOGY LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555001 ANALYER CABLE 12 FT DISPOSABLE CABLE TRANSDUCER AND ELECTRODE DSA REMINGTON MEDICAL, INC. S-101-97-12(1) 1725718

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR