BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3841589 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17490
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION IN ITS ORIGINAL UNOPENED PACKAGE. VISUAL INSPECTION REVEALED THAT THE FORMED SECTION OF THE PACKAGE HAD EVIDENCE OF EXCESSIVE CREASING. THE PACKAGING HAD A DIFFERENT VISUAL APPEARANCE FROM NORMAL IN THAT THE AIR INSIDE THE POUCH HAD BEEN EVACUATED AND THE POUCH MADE A ¿CRINKLING SOUND¿ WHEN HANDLED. THE PACKAGE WAS OPENED, AND THE DEVICE CONTAINED EVIDENCE OF IODINE PRESENT IN THE SPONGE. THE DEVICE WAS THEN WEIGHED, AND THE AMOUNT OF IODINE PRESENT IN THE SPONGE WAS FOUND TO BE OUT OF SPECIFICATION. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED MINICAP, THE DEVICE WAS FOUND TO CONTAIN INADEQUATE IODINE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317940 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13G04H15

    Patients

    Seq Age Sex Outcome Treatment
    1