BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LRGE BORE EXT SET 32IN 4WAY STPCCK NDEHP

    MDR report key: 3113202 · Received May 8, 2013

    Report

    Report Number
    9613251-2013-00137
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 16, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 CRACK; SUBSEQUENTLY, A LEAK WAS NOTED. THE OPTION-LOK MALE ADAPTER OF A PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE 4-WAY STOPCOCK OF THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF PACKED RED BLOOD CELLS (PRBCS), AT 125 ML/HR, VIA PLUM PUMP. THE CUSTOMER CONTACT REPORTED APPROXIMATELY ONE MINUTE AFTER THE DELIVERY WAS STARTED, APPROXIMATELY 5ML OF BLOOD LEAKED FROM A CRACK IN THE FEMALE ADAPTER OF THE 4-WAY STOPCOCK OF THE EXTENSION TUBING SET. THE CUSTOMER CONTACT REPORTED "WHEN THE NURSE WENT TO SEE IF THE CONNECTION SHOULD BE TIGHTENED, IT SNAPPED IN HALF". THE EXTENSION 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 REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202349 LRGE BORE EXT SET 32IN 4WAY STPCCK NDEHP 80FPA FPA HOSPIRA LTD. NA 21031NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NUMBER 12259, LOT NUMBER UNK| PRIMARY PLUMSET Y-TYPE BLOOD TUBING SET, LIST