BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4562267 · Received March 3, 2015

    Report

    Report Number
    1416980-2015-08449
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: 11/19/1204-11/24/2014. THE DEVICE WAS RECEIVED FOR SAMPLE EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION IDENTIFIED THE PRESENCE OF IODINE. THE REPORTED ISSUE WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP HAD A DRY SPONGE. THIS WAS IDENTIFIED BY THE CARE GIVER BEFORE USE. THE REPORTER STATED THAT THERE WAS NO DAMAGE TO THE DEVICE'S PACKAGING. THE DEVICE WAS STORED AT ROOM TEMPERATURE BEFORE THIS OBSERVATION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REPORT 30 OF 53.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145784 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD898205

    Patients

    Seq Age Sex Outcome Treatment
    1