BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PCA SET

    MDR report key: 197015 · Received November 13, 1998

    Report

    Report Number
    197015
    Event Type
    Malfunction
    Date Received
    November 13, 1998
    Date of Event
    November 4, 1998
    Report Date
    November 5, 1998
    Manufacturer
    ABBOTT LABS
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACKAGE OPENED. CHECKED TO SEE IF METAL NEEDLE IN PLASTIC INJECTOR. IT WAS NOT. IF NURSE HADN'T NOTICED THIS, THE PCA WOULD NOT HAVE PUNCTURED AND OR DELIVERED PAIN RELIEF TO THE PT. THIS IS THE SECOND REPORTED INCIDENT. MEMO TO ALL UNITS TO BE AWARE OF THIS. PCA BULLETIN: BEFORE ATTACHING PCA DRUG VIAL TO PUMP VERIFY, BY VISUAL INSPECTION, THAT THE PLUNGER WHICH IS ATTACHED TO THE INFUSION SET HAS THE METAL NEEDLE ATTACHED. IF THIS IS MISSING DO NOT USE THE PCA TUBING/INJECTOR SINCE NO DRUG WILL BE DELIVERED TO THE PT NOR WILL YOU BE ABLE TO ASPIRATE FLUID FROM THE VIAL. THE PCA ADMINISTRATION SET IS DEFECTIVE NOT THE PCA VIAL CONTAINING THE DRUG. RETURN ANY DEFECTIVE SETS TO THE PHARMACY SO WE CAN DOCUMENT AND REPORT THIS PROBLEM TO THE APPROPRIATE AGENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PCA SET PCA INJECTOR MINI BORE MEA ABBOTT LABS * 42 093 NS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other