BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 2431960 · Received January 3, 2012

    Report

    Report Number
    9613251-2012-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    September 1, 2011
    Report Date
    December 8, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE TUBING SET WAS BEING USED TO DELIVER UNSPECIFIED MEDICATION. THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE PATIENT'S IV CATHETER. AFTER AN UNSPECIFIED LENGTH OF TIME, THE SECURE LOCK MALE ADAPTER OF THE TUBING SET DISCONNECTED FROM THE FEMALE ADAPTER OF THE IV CATHETER. IT WAS REPORTED THAT SOLUTION LEAKED AND AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXT SET 7IN REM CLAVE SITE NDEHP 80FPK FPK HOSPIRA LTD. NA 072254W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR: BD MEDICAL| INSYTE IV CATHETER: LIST #UNK