BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    77-301605 20"HIGH PRESSURE LINE W/RA

    MDR report key: 329298 · Received April 23, 2001

    Report

    Report Number
    1123071-2001-00003
    Event Type
    Malfunction
    Date Received
    April 23, 2001
    Date of Event
    December 25, 2000
    Report Date
    April 23, 2001
    Manufacturer
    DEROYAL
    Product Code
    LRP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    3MM CRACK AT 5CM LINE FROM THE MALE LUER LOCK POSITION. THIS OCCURRED DURING THE 8TH IMAGING USING COOK'S HNR CATHETER (4FR. 90CM LENGTH PIGTAIL) WITH 30CC (AT 15CC PER SECOND) OF CONTRAST MEDIUM AT 1200 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18529 77-301605 20"HIGH PRESSURE LINE W/RA 7C1 CATH LAB KITS LRP DEROYAL NA 10973

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other