BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOG CURLIN INFUSION ADMINISTRATION SET

    MDR report key: 20091259 · Received August 27, 2024

    Report

    Report Number
    MW5158928
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ZEVEX, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 I OPENED A MOOG INFUSION ADMIN SET- LOT CF2334323 WITH EXPIRATION 2028-12-09. I NOTICED MULTIPLE BLACK SPECKS ON THE END OF THE TUBING, THE PART THAT CONNECTS TO PATIENT. THE BLACK SPECKS WILL NOT CLEAN OFF, THEY APPEAR TO BE WITHIN THE PLASTIC. I CHECKED MY REMAINING INVENTORY AND DID NOT FIND ANY MORE. THIS HAPPENED IN MY HOME. THIS IS MY DAUGHTER'S SUPPLIES WHO RECEIVES TPN THROUGH A CENTRAL LINE. I DID NOT USE THIS TUBING, I SAVED IT AS EVIDENCE. I REPORTED TO OUR SUPPLIER, (B)(4) AND SENT PHOTOS TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493946 MOOG CURLIN INFUSION ADMINISTRATION SET PUMP, INFUSION FRN ZEVEX, INC. 340-4130 CF2334323

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female BUDESONIDE | CENTRAL LINE IN RIGHT CHEST G-BUTTON| COMPLEAT PEDIATRIC ORGINAL| IV CARNITOR| IV FAMOTIDINE| IV MULTIVITAMINS| PREVACID| SMOF LIPIDS| SULFASALAZINE| TPN| VITAMIN D| ZYRTEC