BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE DISP TRANSPAC IV TRANSDUCER

    MDR report key: 360620 · Received November 8, 2001

    Report

    Report Number
    1713468-2001-00041
    Event Type
    Malfunction
    Date Received
    November 8, 2001
    Date of Event
    October 1, 2001
    Report Date
    October 3, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    BYR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT JAPAN) OF A CRACKED TRANSDUCER WITH BLEED BACK. THE REPORT STATES: "IT WAS NOTICED THAT RUBBER OF SQUEEZE FLUSH HAD CRACKED AND BLOOD DIFFUSED IN FILLER SOLUTION. THERE IS NO HARM TO THE PT." ADDITIONAL INFO WAS REQUESTED, BUT NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49861 SINGLE DISP TRANSPAC IV TRANSDUCER PRESSURE MONITORING KIT BYR ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other