BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3092440 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11254
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12H31095. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2, FOR THE TRANSFER SET IN THIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR THE PERITONEAL. HOWEVER, THE TREATMENT WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194906 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL 1.5% ULTRABAG AND DIANEAL 2.5% ULTRABAG