BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 12682374 · Received October 21, 2021

    Report

    Report Number
    MW5104895
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Report Date
    September 9, 2021
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THERE IS A HOLE IN THE BACK OF THE AIR FILTER THAT LEAKS FLUID WHEN TUBING IS IN USE. PATIENT IS UNABLE TO USE THE TUBING, NO ADVERSE EVENT REPORTED. PATIENT HAS BEEN USING SUPPLY FROM HER PREVIOUS PHARMACY. PRODUCT LOT NUMBER: 4163597. NO OTHER INFORMATION AVAILABLE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? UNKNOWN. DID WE REPLACE PRODUCT? YES; DID THE PATIENT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES; WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6)/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572352 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNK 4163597

    Patients

    Seq Age Sex Outcome Treatment
    1