BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 10704286 · Received October 19, 2020

    Report

    Report Number
    MW5097328
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Report Date
    October 9, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL: PT REPORTS SHE NEEDED HER EXTENSION TUBING REPLACED. NOTICED THAT IT WAS LEAKING FROM THE MIDDLE AND SHE HAS REPLACED IT SINCE THEN. SHE DOES REPLACE MORE OFTEN, SHE THINKS IF SHE GOES LONGER THAN THE ONE DAY, IT MAY LEAK AGAIN. TROUBLESHOT WITH PT BUT REPLACING TUBING ORDER FOR PT. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IF THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO, SHE PROVIDED LOT 3983998. DID WE [MFR] REPLACE DEVICE? YES; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES, IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160007 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21710624 3983998

    Patients

    Seq Age Sex Outcome Treatment
    1