BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP MICR YTYPE CLV

    MDR report key: 2910111 · Received December 6, 2012

    Report

    Report Number
    9613251-2012-00231
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 12, 2012
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL: (B)(4). ADDITIONAL INFORMATION FROM USER FACILITY REPORT FOR BRAND NAME: LIFESHIELD Y-TYPE MICROBORE EXTENSION SET,COMMON DEVICE NAME: Y-TYPE EXTENSION SET, SERIAL # (B)(4), OTHER # PB-0543, (B)(6).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED, "CLAVE CONNECTOR FOUND DISCONNECTED FROM Y EXTENSION TUBING WITH RESULTANT BLOOD LOSS FROM IV SITE BACK THROUGH EXTENSION SET. CHILD'S MOTHER DISCOVERED IN SHORT TIME SUCH THAT BLOOD LOSS WAS MINIMUM. MOTHER FRIGHTENED; CHILD WAS FINE AND DISCHARGED LATER THAT SAME DAY". UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED SEPARATION. THE MALE ADAPTER OF AN UNSPECIFIED PRIMARY TUBING SET WAS CONNECTED TO ONE OF THE CLAVE PORTS OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF 5% DEXTROSE AND 0.9% NORMAL SALINE WITH 20MEQ OF POTASSIUM CHLORIDE AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME AT THE COMPLETION OF THE THERAPY, IT WAS REPORTED THAT THE TUBING OF THE PRIMARY TUBING SET HAD SEPARATED FROM THE CLAVE PORT OF THE EXTENSION TUBING SET. THE CUSTOMER CONTACT REPORTED THAT A "MINIMAL" BLOOD LOSS WAS NOTED. IT WAS REPORTED THAT THE PT'S IV ACCESS WAS DISCONTINUED. 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP MICR YTYPE CLV 80FPK FPK HOSPIRA, LTD. NA 120584W

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO