BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF SET

    MDR report key: 11869775 · Received May 21, 2021

    Report

    Report Number
    MW5101485
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    May 17, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS INBOUND CALL FROM MOTHER ADVISING THAT DURING THEIR LAST INFUSION THE TUBING WAS NOT SECURE RESULTING IN APPROXIMATELY 2/3 OF MEDICATION SPILLING AND NOT INFUSING. PER MRS. (B)(6) THE NEEDLE SET CONNECTION TO SYRINGE FAILED TO LOCK CORRECTLY AND WAS DISCOVERED WHEN PATIENT STOOD UP DURING INFUSION. WHETHER TO MAKE UP DOSE OR WAIT FOR NEXT INFUSION PENDING MD DECISION. UNKNOWN IF DEVICE AVAILABLE FOR RETURN, NO ADVERSE EVENT REPORTED. NO OTHER INFORMATION PROVIDED. UNKNOWN IF THERE WAS ANY CONNECTION TO THE ACTUAL VIAL THAT LEAKED. INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761036 TUBING FREEDOM 60 SYR INF SET PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS P100014491

    Patients

    Seq Age Sex Outcome Treatment
    1