BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP

    MDR report key: 3113197 · Received May 8, 2013

    Report

    Report Number
    9615050-2013-01105
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. 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 THE PIERCING PIN OF TUBING SET PUNCTURED THE BLOOD PRODUCT CONTAINER. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF PACKED RED BLOOD CELLS (PRBCS). THE CUSTOMER CONTACT REPORTED THAT WHEN THE NURSE INSERTED THE PIERCING PIN OF THE TUBING SET INTO THE ADMINISTRATION PORT OF THE BLOOD CONTAINER, THE PIERCING PIN PUNCTURED THE WALL OF THE BLOOD CONTAINER. THE CUSTOMER CONTACT REPORTED THAT A "MINIMAL" VOLUME OF BLOOD LEAKED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE REPLACEMENT UNIT OF PRBCS WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EVENTS AND NO REPORTED DELAY IN CRITICAL THERAPY TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202388 PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 161395H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED BLOOD CONTGAINER: MFR FENWAL, INC.