BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCOMP HEMOCATH 12.5FR 18CM

    MDR report key: 12829719 · Received November 16, 2021

    Report

    Report Number
    MW5105393
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 15, 2021
    Manufacturer
    MEDCOMP / MEDICAL COMPONENTS INC.
    Product Code
    NIE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD MEDCOMP HEMOCATH 12.5 FR 18 CM, LOT #: MPDL180S2, SILICONE PLACED (B)(6) 2021. NOTED TO HAVE PINHOLES (2) IN EXTERIOR RED LUMEN OF CATHETER. THIS IS 3RD PATIENT WITH THIS DEFECT NOTED IN THIS CATHETER, ALL REPORTED THROUGH MEDCOMP. THERAPY START DATE: (B)(6) 2021; STOP DATE: (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716357 MEDCOMP HEMOCATH 12.5FR 18CM CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE MEDCOMP / MEDICAL COMPONENTS INC. MPDL180S2
    1716358 MEDCOMP HEMOCATH 12.5FR 18CM CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE MEDCOMP / MEDICAL COMPONENTS INC.
    1716359 MEDCOMP HEMOCATH 12.5FR 18CM CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE MEDCOMP / MEDICAL COMPONENTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention| H