BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICAL DISPOSABLES

    MDR report key: 277768 · Received May 9, 2000

    Report

    Report Number
    1033554-2000-00007
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Manufacturer
    DEROYAL
    Product Code
    DTL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED TO DISTRIBUTOR THAT CONNECTING TUBING CRACKED AND SPLIT DURING INJECTION OF CONTRAST MEDIA. USER FACILITY REPORTED INCIDENTS OCCURRED DURING SEVERAL PROCEDURES WITH AT LEAST 6 PTS RECEIVING MORE CONTRAST THAN WAS NEEDED. USER FACILITY COULD NOT PROVIDE EXACT NUMBER OF INCIDENTS.

    Description of Event or Problem · 1

    AS INDICATED IN THE INITIAL REPORT, THE CONNECTING TUBING CRACKED AND SPLIT DURING INJECTION OF CONTRAST MEDIA. THE USER FACILITY COULD NOT PROVIDE THE EXACT NUMBER OF INCIDENTS, BUT REPORTED THAT 6 PTS RECEIVED MORE CONTRAST THAN WAS NECESSARY. THIS FOLLOW-UP REPORT IS TO CONFIRM THAT THE INFO PROVIDED IN THE INITIAL MEDWATCH REPORT # 1033554-2000-0007 IS FOR THE FIRST PT WHO RECEIVED MORE CONTRAST THAN WAS NECESSARY. THE USER FACILITY REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRITICAL DISPOSABLES 48" HIGH PRESSURE LINE CPC F R/A DTL DEROYAL NA 026464

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other