BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/SOLUTION CONTINU-FLO SETW/INTERLINK INJ SITE/NON-RETUR

    MDR report key: 1932584 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05988
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. DELIVERY TEST WAS PERFORMED WITH NO ABNORMALITY OBSERVED. BATCH REVIEW WAS ALSO PERFORMED ON THE REPORTED BATCH WITH NO ABNORMALITY OBSERVED. BASED ON THE EVALUATION RESULTS ON THE RETURNED SAMPLE, THE REPORTED COMPLAINT CANNOT BE CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A BLOOD SOLUTION CONTINU FLO SET THAT WAS OCCLUDED AND COULD NOT BE PRIMED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD/SOLUTION CONTINU-FLO SETW/INTERLINK INJ SITE/NON-RETUR SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - SINGAPORE S10A27116R

    Patients

    Seq Age Sex Outcome Treatment
    1