BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I/L Y-TYPE BLOOD SOLUTION SET

    MDR report key: 1847889 · Received September 29, 2010

    Report

    Report Number
    6000001-2010-03560
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. ADDITIONALLY A LABELING REVIEW WAS PERFORMED AND THE DIRECTIONS FOR USE CALL OUT THE USE OF AN INTERLINK CANNULA FOR ACCESS OF THE INJECTION SITE. PER THE CUSTOMER, THE CLINICIAN USED A (B)(4) SMART TIP VIAL ACCESS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE THAT THE INTERLINK Y-TYPE BLOOD/SOLUTION SET LEAKED FROM THE INTERLINK INJECTION SITE. THE LEAK OCCURRED IMMEDIATELY AFTER A (B)(4) SMARTIP VIAL ACCESS PRODUCT ((B)(4)) WAS USED TO ACCESS THE INTERLINK. THE CLINICIAN BELIEVES IT WAS THE PATIENT'S BLOOD THAT LEAKED AND NOT THE TRANSFUSION BLOOD. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I/L Y-TYPE BLOOD SOLUTION SET SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO UR10E26192

    Patients

    Seq Age Sex Outcome Treatment
    1