BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3803280 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15102
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL OCCURRENCE DATE IS UNKNOWN. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER GD896308 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. ALTHOUGH A NONCONFORMANCE WAS NOTED IN THIS BATCH, IT WAS DETERMINED TO NOT BE ASSOCIATED WITH THE REPORTED PROBLEM. THE SAMPLE WAS RECEIVED WITH AN OPEN POUCH AND EVALUATED, BUT THE ISSUE OF INADEQUATE IODINE COULD NOT BE VERIFIED THROUGH THE DEVICE EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND BECAUSE THE IODINE WAS DETECTED ON THE CAP¿S SPONGE. THE SEAL INTEGRITY OF THE POUCH WAS FOUND TO BE INTACT AND THERE WAS NO FLAW OR DAMAGE TO THE FOIL. THE DEVICE WAS FOUND TO HAVE MET THE SPECIFICATION RELATED TO THE REPORTED PROBLEM. THE REPORTED ISSUE OF INADEQUATE IODINE COULD NOT BE VERIFIED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADDITIONAL SAMPLES OF THE MINICAPS WERE RECEIVED FOR EVALUATION THAT WERE LATER ALLEGED TO HAVE INADEQUATE IODINE. DURING THE FOLLOW UP WITH THE PATIENT, THEY CLARIFIED THAT THEY RETURNED ADDITIONAL SAMPLES FROM THE SAME BOX BECAUSE THEY BELIEVED THERE WAS INADEQUATE IODINE IN THOSE MINICAPS AS WELL. THE PATIENT EXPLAINED THAT THESE WERE THE CAPS WHERE THEY NOTICED A LIGHTER COLOR OF IODINE THAN USUAL (LIGHT ORANGE INSTEAD OF ORANGE). ALL OF THE MINICAPS WERE STORED AT ROOM TEMPERATURE AND THEIR PACKAGING WAS INTACT PRIOR TO NOTICING THE REPORTED ISSUE. THERE WERE NO DEFECTS SEEN ON THE MINICAPS AND THE PATIENT DID NOT USE THEM. THE PATIENT THOUGHT THAT THE SPONGES WERE DRIED OUT AND THEY EXPLAINED THAT THEY HAD EVEN TESTED FOR IODINE BY TWISTING THE MINCAPS TO SEE IF COLOR CHANGED OR IF IODINE DRIPPED, BUT NOTHING HAPPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280932 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896308

    Patients

    Seq Age Sex Outcome Treatment
    1