BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1 SOLUTION

    MDR report key: 1033510 · Received April 23, 2008

    Report

    Report Number
    1423500-2008-00274
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S NURSE IS UNSURE IF THE SAMPLE IS AVAILABLE.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER AND REPORTED THAT A MINICAP DISCONNECT CAP FELL OFF A PATIENT'S TRANSFER SET. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP CALL WITH THE NURSE, IT WAS LEARNED THAT THE PT HAS CONTINUED THERAPY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1 SOLUTION DISCONNECT CAP / 78KDJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1