BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 3CLV YSTE MACR

    MDR report key: 2181097 · Received July 7, 2011

    Report

    Report Number
    9613251-2011-00157
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 13, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE BY GRAVITY FLOW. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PATIENT'S IV ACCESS SITE. AT AN UNSPECIFIED TIME, A MALE ADAPTER OF AN UNSPECIFIED DEVICE WAS CONNECTED TO AN UNSPECIFIED CLAVE Y-SITE ON THE TUBING SET TO DELIVER AN UNSPECIFIED ANESTHETIC MEDICATION VIA IV PUSH. IT WAS REPORTED THAT AFTER THE DELIVERY OF THE ANESTHETIC MEDICATION WAS STARTED, A LEAK OF SOLUTION AND AN UNSPECIFIED VOLUME OF BLOOD LOSS WERE NOTED FROM AN UNSPECIFIED LOCATION NEAR THE CONNECTION OF THE OPTION-LOK MALE ADAPTER AND THE PATIENT'S IV ACCESS SITE. IT WAS REPORTED THAT THE TUBING WAS CLAMPED PROXIMAL TO THE OPTION-LOK MALE ADAPTER. IT WAS REPORTED THAT AFTER A NEW PERIPHERAL IV ACCESS SITE WAS STARTED, THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 3CLV YSTE MACR 80FPA FPA HOSPIRA, LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1