BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD - EXTENSION SET

    MDR report key: 11046072 · Received December 18, 2020

    Report

    Report Number
    MW5098463
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 11, 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 INBOUND CALL FROM PATIENT REGARDING CADD EXT SET/TUBING. THE SHIPMENT FROM PHARMACY ON 11/09/2020 CONTAINED CADD EXT WITH A SMALL HOLE IN EACH WHERE THE TUBING CONNECTS TO A FILTER. THE PATIENT EXPLAINED THE HOLE WAS SO SMALL THAT HE WASN'T LOSING A SIGNIFICANT AMOUNT OF MEDICATION, BUT MOISTURE WAS "SEEPING" THROUGH IT, THIS RAISED CONCERN FOR STERILITY, EVERY ONE OF THE 15 OF THESE SHIPPED TO PATIENT HAD THIS DEFAULT. PATIENT WAS SENT A NEW SUPPLY FROM A DIFFERENT LOT NUMBER ON 12/11/2020. LOT NUMBER IN QUESTION IS 4034004. PATIENT SUCCESSFULLY UTILIZED THE NEW SETS. PATIENT HAS OLD TUBING ON HAND IN NEED OF RETRIEVAL. DID WE [MFR] PLACE DEVICE? YES, DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES, IS THE INFUSION LIFE-SUSTAINING? YES. 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 DEVICE AVAILABLE FOR INVESTIGATION? YES. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499060 CADD - EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4034D04

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR