BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR® LUER LOCK ADAPTOR

    MDR report key: 7897267 · Received September 21, 2018

    Report

    Report Number
    7897267
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 16, 2018
    Report Date
    September 14, 2018
    Manufacturer
    TEVA PHARMACEUTICAL INDUSTRIES LIMITED
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BOTH CSTD COMPONENTS BECAME DISCONNECTED ALONG WITH THE CAREFUSION NEEDLE FREE VALVE (INJECTION CAP) THAT WE USE. THE LINE BECAME DISCONNECTED LEAVING THE CENTRAL LINE OPEN AND BLEEDING OUT. THE PATIENT WAS DISCOVERED BECAUSE BED ALARM WENT OFF. THERE HAVE BEEN SEVERAL OTHER DISCONNECTS WHERE THE CSTD DISCONNECTS FROM THE TUBING AND WE ARE WAITING ON A PRODUCT UPDATE TO FIX THAT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740282 TEVADAPTOR® LUER LOCK ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB TEVA PHARMACEUTICAL INDUSTRIES LIMITED MG412114

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA