BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE

    MDR report key: 213032 · Received March 4, 1999

    Report

    Report Number
    MW1015826
    Event Type
    Injury
    Date Received
    March 4, 1999
    Date of Event
    November 6, 1998
    Report Date
    November 9, 1998
    Manufacturer
    DATASCOPE CORP CARDIAC ASSIST
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MFR. ON 04/09/1999: BASED ON THE PHYSICAL EVIDENCE, THE LEAK WAS DUE TO THE CRACK IN THE YELLOW FEMALE LUER FITTING (Y-FITTING HUB LUER). WHILE IT IS NOT POSSIBLE TO DETERMINE WHEN THE CRACK WAS CREATED, IT IS LIKELY THAT OVER TIGHTENING OF THE LUER CAP OR PRESSURE MONITORING TUBING DURING IABP MAY HAVE RESULTED IN THE CRACKING OF THE LUER FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE Implant INTRA-AORTIC BALLOON CATHETER CL8 DSP DATASCOPE CORP CARDIAC ASSIST 20010330 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention