BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL LINE

    MDR report key: 12616599 · Received October 8, 2021

    Report

    Report Number
    MW5104546
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 1, 2021
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED HOSPITALIZED FROM (B)(6) 2021 THROUGH (B)(6) 2021 FOR BROKEN CENTRAL LINE. LINE WAS REPLACED, NO FURTHER ISSUES. NO FURTHER INFO. PATIENT REMS ID:(B)(6), MD REMS ID:(B)(6). REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498916 CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization