BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 3912699 · Received May 14, 2014

    Report

    Report Number
    9613251-2014-00102
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 17, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE EXTENSION TUBING SET WITH A REMOVABLE CLAVE PORT WAS TO BE USED FOR INTERMITTENT DELIVERIES. THE CUSTOMER CONTACT REPORTED THAT A 30ML SYRINGE FILLED WITH NORMAL SALINE WAS CONNECTED TO THE CLAVE PORT AND THE TUBING SET WAS PRIMED. IT WAS REPORTED THAT AFTER THE TUBING SET WAS PRIMED, THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT'S IV CATHETER. THE CUSTOMER CONTACT REPORTED THE PT'S CATHETER WAS THEN FLUSHED, THE SYRINGE WAS DISCONNECTED FROM THE CLAVE PORT AND THE TUBING AS CLAMPED WITH THE SLIDE CLAMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PT WAS TRANSPORTED TO THE CT DEPT FOR AN UNSPECIFIED CT SCAN PROCEDURE. AT THAT TIME, THE SLIDE CLAMP OF THE TUBING SET WAS OPENED IN ORDER TO CONNECT AN UNSPECIFIED TUBING SET FOR A DELIVERY OF CONTRAST MEDIUM. THE CUSTOMER CONTACT REPORTED THAT AFTER THE SLIDE CLAMP WAS UNCLAMPED, AN UNSPECIFIED VOLUME OF BLOOD LEAKED ONTO THE BED SHEET. IT WAS REPORTED THE TUBING WAS IMMEDIATELY CLAMPED WITH THE SLIDE CLAMP. AT THAT TIME, IT WAS REPORTED THAT THE REMOVABLE CLAVE PORT WAS DISCONNECTED FROM THE TUBING SET AND THE REMOVABLE CLAVE PORT WAS REPLACED AND THE THERAPY WAS INITIATED. DURING VISUAL EXAMINATION OF THE CLAVE PORT A THE USER FACILITY, IT WAS REPORTED THAT REPORTEDLY THE SILICONE SLEEVE OF THE CLAVE PORT WAS MISSING. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288038 EXT SET 7IN REM CLAVE SITE NDEHP 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT UNSPECIFIED 30ML SYRINGE, MFR UNK| UNSPECIFIED IV CATHETER, LIST UNK, MFR UNK