BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T HOLDER

    MDR report key: 4609398 · Received March 11, 2015

    Report

    Report Number
    MW5041468
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 11, 2015
    Manufacturer
    SMITHS MEDICAL
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS USING A SAF-T HOLDER TO DRAW BLOOD FROM A PICC LINE. WHEN SHE TRIED TO DISCONNECT OR UNSCREW THE DEVICE FROM THE PICC LINE, THE MALE LUER CONNECTOR OF THE SAF-T HOLDER BROKE OFF INSIDE THE CAREFUSION MAXPLUS NEEDLESS CONNECTOR THAT WAS ATTACHED TO THE PICC. THE MAXPLUS CONNECTOR NEEDED TO BE REPLACED ON THE PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166391 SAF-T HOLDER BLOOD COLLECTION DEVICE JKA SMITHS MEDICAL 96000 *
    166392 MAXPLUS NEEDLESS CONNECTOR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CAREFUSION MAXPLUS NEEDLESS CONNECTOR