BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET TUBING

    MDR report key: 12662636 · Received October 18, 2021

    Report

    Report Number
    MW5104754
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Report Date
    May 7, 2021
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS. PT REPORTS 4 OF HER CADD EXTENSION SETS LEAKED AROUND THE FILTER AREA; DATE NOT PROVIDED. LOT NUMBER 4091449, EXPIRATION DATE 01/04/2026. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE [MFR] THE DEVICE? YES; DID THE PT HAVE A BACKUP THEY WERE ABLE TO SWITCH TO? YES; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550184 CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA UNK 4091449
    1550185 CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA 4091449
    1550186 CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA 4091449
    1550187 CADD EXTENSION SET TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA 4091449

    Patients

    Seq Age Sex Outcome Treatment
    1