BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT

    MDR report key: 3969963 · Received July 28, 2014

    Report

    Report Number
    3969963
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 28, 2014
    Manufacturer
    TELEFLEX INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIA FELLOW WAS GETTING READY TO PLACE A CENTRAL LINE INTO THE PATIENT. AS HE WAS SETTING UP HIS 9FR MAC CATHETER KIT, HE NOTICED THE END OF THE DILATOR WAS SERRATED AND BROKEN. THE DEFECT WAS VISUALLY EVIDENT PRIOR TO USE AND UPON OPENING THE KIT. HE BROUGHT THE PROBLEM TO THE ATTENTION OF THE ANESTHESIOLOGIST AND ANESTHESIA TECHNICIAN, WHO BOTH AGREED THAT THE DEVICE WAS IMPROPERLY MANUFACTURED. THE ALTERED DILATOR WAS DISPOSED OF AND A NEW KIT WAS OPENED AND INSPECTED BEFORE PROCEEDING WITH THE CASE. THERE WERE NO ISSUES WITH THE SECOND KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440086 ARROW MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT CATHETER INTRODUCER KIT DQO TELEFLEX INC. CDC-11241-1A 23F14A1091

    Patients

    Seq Age Sex Outcome Treatment
    1 *