BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR SYRINGE ADAPTOR

    MDR report key: 12953349 · Received December 6, 2021

    Report

    Report Number
    MW5105849
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 2, 2021
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFUSION LEAKED FROM AROUND THE TEVADAPTOR (SYRINGE ADAPTOR FOR ONGUARD SYSTEM) CONNECTION AND NEEDED TO BE REPLACED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843316 TEVADAPTOR SYRINGE ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. UA8577

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female