BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4130232 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33892
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. AN OPEN SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THREADS NOTED INSIDE THE SAMPLE. THE REPORTED PROBLEM COULD NOT BE IDENTIFIED THROUGH A SAMPLE EVALUATION. 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 DID NOT HAVE ANY THREADING ON THE INSIDE OF THE CAP. THIS WAS FOUND DURING USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607459 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1305010

    Patients

    Seq Age Sex Outcome Treatment
    1