BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET W/LL T-CONNECTOR

    MDR report key: 375938 · Received February 5, 2002

    Report

    Report Number
    9610175-2002-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2002
    Date of Event
    December 27, 2001
    Report Date
    January 15, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT-JAPAN) WHICH STATES "THE CUSTOMER NOTICED THAT THE STOPPER AND BAND DISCONNECTED FROM THE T-CONNECTOR, AND DROPPED DOWN THE BEDSIDE SPONTANEOUSLY. THE DEVICE WAS USED FOR A PREMATURE BABY. A SYRINGE PUMP WAS INFUSING SALINE WERE HEPARIN THROUGH THE VEIN. AT 10AM IN 2001, THERE WAS NO PROBLEM WITH THE PATIENT WHEN THE CUSTOMER INJECTED AN ANTIBIOTIC TO THE PATIENT. AT 10PM THAT DAY, THE CUSTOMER NOTICED THE STOPPER AND BAND DISCONNECTED WHEN TRYING TO INJECT THE ANTIBIOTIC. THE HOSPITAL CONNECTED THE CATHETER (20 CM) AND THE CUSTOMER NOTICED THE EVENT BEFORE BLOOD WAS COMING UP THE END OF THE CATHETER. THERE WAS NOT ANY BLEEDING OR HARM TO THE PATIENT." ADDITIONAL INFORMATION RECEIVED STATES, "EVERY 10:00AM AND 10:00PM, THE ANTIBIOTIC DRUG WAS DISPENSED THROUGH THE T-CONNECTOR BY 1-2ML PER HOUR. AT 10:00 PM ON THAT DAY, THE DOCTOR FOUND THAT THE RUBBER STOPPER AND PLASTIC SHRINK SEAL REMOVED OFF THE T-CONNECTOR. THE CUSTOMER DISINFECTED THE STOPPER AND BAND WITH ALCOHOL. THE SET HAD BEEN ON THE PATIENT SINCE 12/01. THE CATHETER CONNECTED TO THE T-CONNECTOR WAS INSERTED INTO THE PATIENT'S LEG VEIN, AND THE CATHETER WAS FIXED ON THE LEG BY ADHESIVE TAPE." ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION HAS BECOME AVAILABLE.

    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 1 MO Other CATHETER AND AN UNSPECIFIED SYRING PUMP.