BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2851529 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06164
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A PACKAGING RELATED DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED BAXTER (B)(4) REGARDING A PACKAGING ISSUE WITH A MINICAP. THE DISTRIBUTOR STATED THAT THE OVER POUCH OF THE MINICAP HAD A BAD SEAL ON IT. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1203010

    Patients

    Seq Age Sex Outcome Treatment
    1