BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 469589 · Received June 30, 2003

    Report

    Report Number
    9613251-2003-00091
    Event Type
    Malfunction
    Date Received
    June 30, 2003
    Date of Event
    June 17, 2003
    Report Date
    June 19, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN EXTENSION SET THAT "SPLIT" DURING A POWER INJECTION OF CONTRAST MEDIA. THE PT HAD AN UPPER EXTREMITY ANTECUBITAL IV ACCESS. OMNIPAQUE CONTRAST WAS INJECTED WITH A MEDRAD POWER INJECTOR VIA THE EXTENSION SET AT A RATE OF 1.6ML/SEC WITH A PSI OF 250. THE TOTAL AMOUNT TO BE INJECTED WAS 100ML. AFTER RECEIVING APPROXIMATELY 60ML, THE PT REPORTEDLY "FLEXED HIS ARM", AND THE TUBING "SPLIT". THE PT WAS "SPRAYED" WITH CONTRAST, BUT THERE WAS NO REPORTED SKIN REACTION. THE CUSTOMER REPORTED THAT THERE WAS 2ML TO 3ML OF BLEED BACK. THE ACCESS WAS REMOVED FROM THE PT, AND NO INFILTRATION WAS NOTED AT THE SITE. THE STUDY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO REPORTED ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROBORE EXTENSION SET W/LL T-CONNECTOR ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other MEDRAD POWER INJECTOR-MEDRAD, INC.-MFR.| INC.- MANUFACTURER.| OMNIPAQUE CONTRAST-AMERSHAM. HEALTH-MFR.