BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3832802 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17011
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 2, 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). (B)(6). EVALUATION SUMMARY: DURING THE INVESTIGATION OF (B)(4), AN ADDITIONAL SAMPLE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AGAINST THE REPORTED CONDITION OF INADEQUATE IODINE. VISUAL INSPECTION REVEALED THAT THE FORMED SECTION OF THE PACKAGE HAD EVIDENCE OF EXCESSIVE CREASING. THE PACKAGING HAD A DIFFERENT VISUAL APPEARANCE THAN EXPECTED IN THAT THE AIR INSIDE THE POUCH HAD BEEN EVACUATED AND THE POUCH MADE A ¿CRINKLING SOUND¿ WHEN HANDLED. THE SAMPLE WAS WEIGHED AND WAS FOUND TO HAVE AN INSUFFICIENT AMOUNT OF IODINE PRESENT. ADDITIONALLY, PIN-HOLES WERE OBSERVED IN THE FOIL LAYER OF THE FORMED CAVITY OF THE POUCH. THESE PIN HOLES WERE ONLY IN THE FOIL LAYER OF THE POUCH MATERIAL AND DID NOT PIERCE THROUGH OTHER LAYERS OF THE MATERIAL. THE ORIGINAL REPORTED CONDITION WAS VERIFIED THROUGH THE SAMPLE EVALUATION. THE CAUSE OF THIS CONDITION WAS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION AND EVALUATION. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THE ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT WHEN THEY OPENED THE OVER-POUCH TO THEIR MINICAP, THE IODINE SOLUTION APPEARED TO BE INSUFFICIENT, RELATIVE TO THEIR NORMAL BATCHES. THIS OBSERVATION WAS MADE PRIOR TO USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310777 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13G04H15

    Patients

    Seq Age Sex Outcome Treatment
    1