BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-LOCK DISCONNECT CAP WITH PROVIDONE-IODINE

    MDR report key: 471129 · Received July 7, 2003

    Report

    Report Number
    1423500-2003-00696
    Event Type
    Malfunction
    Date Received
    July 7, 2003
    Date of Event
    June 1, 1998
    Report Date
    June 3, 2003
    Manufacturer
    BAXTER HEALTHCARE, LTD.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) REPORTS APPROXIMATELY 25 INCIDENTS OF THE DISCONNECT CAP POPPING OFF OF THE PT EXTENSION LINE DURING HI-DOSE APD THERAPY OVER THE PAST FIVE YEARS. NOTED DURING USE, UPON RETURNING TO COMPLETE THE HP'S NIGHT EXCHANGES. THE HP REPLACED ALL SUPPLIES AND THERAPIES WERE COMPLETED WITHOUT INCIDENT. NO PT INJURY OR MEDICAL INTERVENTION REPORTED PER HP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY-LOCK DISCONNECT CAP WITH PROVIDONE-IODINE DISCONNECT CAP KDJ BAXTER HEALTHCARE, LTD. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 5C4471 - HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT,| 4-PRONG, DATE UNK.| UNK.| DATE UNK.| 5C4469 - HOMECHOICE AUTOMATED PD SET W/CASSETTE| CONNECTOR, DATE UNK.| 5C4480P - 12 FT. EXTENSION SET, EASY LOCK| LOW CALCIUM DIANEAL SOLUTION, STRENGTH UNK, DATE