BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET

    MDR report key: 13282700 · Received January 14, 2022

    Report

    Report Number
    MW5106696
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Report Date
    December 1, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED CADD EXT SET TUBING MALFUNCTION (LOT NUMBER 4163598). SHE NOTICED THAT FOR ONE SET, THE THREADS ON THE TUBING WERE SHOT AND RESULTED IN HER TUBING DISCONNECTING. SHE SAID IT SEEMS LIKE THE TUBING FROM THIS LOT NUMBER HAS THREADS THAT WON'T STAY SECURE AND KEEPS COMING DISCONNECTED. AND TODAY, SHE HAD TO CHANGE HER TUBING BECAUSE SUDDENLY SHE FELT WET AND WHEN SHE LOOKED TO SEE WHAT WAS GOING ON, HER TUBING WAS ALMOST BROKEN IN HALF/RIPPED. ALL PROBLEMATIC TUBING IS FROM LOT NUMBER 4163598. ADVISED THAT WE WILL HAVE TUBING OF A DIFFERENT LOT NUMBER SENT. UNKNOWN HOW MANY EXTENSION SETS PATIENT HAS FROM THIS LOT. NO OTHER INFORMATION KNOWN. DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. SENDING REPLACEMENT TUBING OF DIFFERENT LOT. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE IS AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES, AS LONG AS PT RETAINS IT. DID WE MFR REPLACE THE DEVICE? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520123 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4163598

    Patients

    Seq Age Sex Outcome Treatment
    1 Female