BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP PREP KITS

    MDR report key: 3983869 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25443
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL DEVICE WAS NOT RECEIVED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER, A PICTURE OF THE SAMPLE WAS RECEIVED AND WAS VISUALLY INSPECTED. A CRACK WAS NOTED IN THE MINICAP. THE CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY OF THE MINICAP WAS NOTIFIED OF THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP IN A PREP KIT WAS FOUND TO HAVE CRACKS. THERE WERE NO ALLEGATIONS AGAINST THE OTHER COMPONENTS OF THE KIT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459398 MINICAP PREP KITS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SAO PAULO PS44S5

    Patients

    Seq Age Sex Outcome Treatment
    1