BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV PRM 1LWR CLV 100"

    MDR report key: 1944229 · Received December 6, 2010

    Report

    Report Number
    9613251-2010-00174
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 11, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED REPORTED DEVICE BREAKAGE; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING SET WAS USED TO DELIVER AN UNSPECIFIED MEDICATION. THE MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A CLAVE CLC2000 WHICH WAS CONNECTED TO THE PT'S PICC LINE. IT WAS REPORTED THAT AFTER THE MEDICATION WAS DELIVERED, THE NURSE DISCONNECTED THE MALE ADAPTER OF THE TUBING SET FROM THE CLAVE DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE RETURNED TO THE PT'S ROOM AND NOTED AN UNSPECIFIED VOLUME OF BLOOD ON THE PT'S BED. THE NURSE CLAMPED THE PT'S PICC LINE. AT THIS TIME, THE NURSE NOTED THAT THE TIP OF THE MALE ADAPTER OF THE TUBING SET THAT HAD BEEN REMOVED WAS STUCK IN THE CLAVE CLC2000. THIS ALLOWED THE CLAVE TO REMAIN IN THE OPEN POSITION. THE CLAVE CLC2000 WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV PRM 1LWR CLV 100" 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST #12309, LOT #UNK, (B)(4)| CLAVE CLC2000 NEEDLEFREE CATHETER PATENCY DEVICE