BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONGUARD 2 CSTD SYRINGE ADAPTOR LOCK II

    MDR report key: 24793913 · Received April 6, 2026

    Report

    Report Number
    MW5186383
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    SIMPLIVA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT AT HOME WITH FLUOROURACIL CONTINUOUS INFUSION INFUSING THROUGH CADD PUMP. PATIENT FELT WETNESS ON SHIRT AND DISCOVERED THAT TUBING HAD SPONTANEOUSLY DISCONNECTED FROM CLOSED SYSTEM DRUG-TRANSFER DEVICE ADAPTOR ATTACHED TO HIS PORT WHICH ALLOWED BLOOD TO BACK FLOW. SIGNIFICANT AMOUNT OF BLOOD LEAKING FROM PORT. PATIENT CALLED INFUSYSTEM 24/7 NURSING HOTLINE AND WAS EDUCATED TO CLAMP PORT WHICH STOPPED BLEEDING. PRESENTED TO INFUSION CENTER TO HAVE PUMP/TUBING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565775 ONGUARD 2 CSTD SYRINGE ADAPTOR LOCK II CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVA HEALTHCARE LTD 412174 UBY591

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention WALKMED PUMP RESERVOIR