BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 14623414 · Received June 6, 2022

    Report

    Report Number
    MW5110147
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 27, 2022
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS COMMUNICATION FROM (B)(6) (MEDICAL ASSISTANT FOR DOCTOR'S OFFICE) AND SHE STATED THAT THE PATIENT INFUSED ON WEDNESDAY ((B)(6) 2022) AND WHEN SHE GOT TO THE THIRD SYRINGE OF HIZENTRA, THE TUBING FELT LOOSE AND MEDICATION WOULD NOT COME OUT. THE TUBING DISCONNECTED AND THE MEDICATION GOT EVERYWHERE. PATIENT WAS UNABLE TO FINISH INFUSION AND MISSED THE DOSE. UNKNOWN IF THE DOCTOR OFFICE STILL HAS THE DEFECTIVE DEVICE ON HAND. UNKNOWN IF ANY OTHER ADVERSE EVENT OCCURRED. NO OTHER INFORMATION REPORTED. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? UNK; DID WE [MFR] REPLACE THE DEVICE? YES; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? NO; MEDLINE INDUSTRIES, INC.; REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599896 TUBING FREEDOM 60 SYR INF PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female