BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4100981 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32160
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER STATED THAT TAPE WAS USED TO ATTEMPT TO SECURE THE MINICAP DURING THIS EVENT. THIS IS REPORT 1 OF 6. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: 4/11/14-4/17/14. EXPIRATION DATE: OCTOBER 2015. A COMPANION SAMPLE WAS RECEIVED BY BAXTER FOR INVESTIGATION. A VISUAL AND FUNCTIONAL TEST WAS PERFORMED WITH NO ABNORMALITIES NOTED. A BATCH REVIEW WAS CONDUCTED ON LOT NUMBER GD896845 AND GD897108 AND THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. 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 WITH POVIDONE-IODINE SOLUTION WAS NOT ATTACHING PROPERLY AND LEAKED IODINE. THIS OCCURRED DURING PATIENT USE. THE REPORTER STATED THAT NO DAMAGE TO THE MINICAP OR ITS PACKAGING WAS NOTICED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585055 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896845

    Patients

    Seq Age Sex Outcome Treatment
    1