BEUDAMED
    FDA Adverse Event Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 2112447 · Received March 8, 2011

    Report

    Report Number
    9613251-2011-00099
    Date Received
    March 8, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PATIENT'S PROTECTIV PLUS 20 GAUGE IV CATHETER. THE TUBING SET WAS BEING USED AS A SALINE LOCK. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE PATIENT NOTED A LEAK OF BLOOD AT THE ACCESS SITE. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. AFTER THE NURSE EXAMINED THE ACCESS SITE, IT WAS REPORTED THAT THE SECURE LOCK MALE ADAPTER DISCONNECTED FROM THE IV CATHETER. THE TUBING SET WAS REPRIMED WITH NORMAL SALINE, RECONNECTED TO THE IV CATHETER 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 966014W

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR