BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK I.V. CATHETER EXT SET/MALE LL ADAPTER

    MDR report key: 2040236 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02581
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(6) 2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THE UNIT WAS INCOMPLETE - MISSING A PIECE OF TUBING. THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THIS CONDITION OCCURRED DURING THE PACKAGING PROCESS DUE TO A SECTION OF TUBING PROTRUDING OUT OF THE POUCH DURING THE PACKAGING SEALING PROCESS. THE ROOT CAUSE WAS UNDETERMINED; HOWEVER, THE MANUFACTURING FACILITY HAS PROVIDED AWARENESS TRAINING FOR THE PACKAGING OPERATORS. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN UNKNOWN QUANTITY OF INTERLINK SYSTEM I.V. CATHETER EXTENSION SETS IN WHICH THE TUBING IS BROKEN. IT IS UNKNOWN WHEN THE CONDITION WAS IDENTIFIED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK I.V. CATHETER EXT SET/MALE LL ADAPTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1