BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4213470 · Received October 30, 2014

    Report

    Report Number
    1416980-2014-37981
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 7, 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

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPIRATION DATE OF THE REPORTED LOT IS DECEMBER 2015. THIS LOT WAS MANUFACTURED FROM 20 JUN 2014 THROUGH 27 JUN 2014. THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE OF INADEQUATE IODINE. A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBER GD897165 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED AND IODINE WAS DETECTED ON THE SPONGE OF THE MINICAP. FUNCTIONAL INSPECTION OF THE PACKAGING COULD NOT BE PERFORMED AS THE POUCHES WERE ALREADY OPENED. A REVIEW OF THE PRODUCTION RECORDS WAS PERFORMED AND BETADINE LEVELS ADMINISTERED TO THE DEVICE WERE FOUND TO BE WITHIN SPECIFICATION. UPON CONCLUSION OF THE INVESTIGATION, THE RETURNED SAMPLE MET PRODUCT SPECIFICATIONS AND THE REPORTED ISSUE COULD NOT BE VERIFIED. THE CAUSE OF THE REPORTED ISSUE OF INADEQUATE IODINE COULD NOT BE DETERMINED. 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 HAD INADEQUATE IODINE. THE CARE GIVER STATED THAT THE MINICAP WAS COMPLETELY DRIED OUT. THE MINICAP PACKAGING WAS NOT OPENED OR DAMAGED PRIOR TO USAGE AND WAS STORED AWAY FROM HEATING AND COOLING SOURCES. THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696218 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD897165

    Patients

    Seq Age Sex Outcome Treatment
    1