BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 8621825 · Received May 17, 2019

    Report

    Report Number
    1416980-2019-02758
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2019. THE DEVICES WERE RECEIVED AND ARE CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    TWO (2) SAMPLES WERE RECEIVED FOR EVALUATION WITH THE ALUMINUM FOIL PEELED. A VISUAL INSPECTION PERFORMED WITH THE NAKED EYE VERIFIED THAT THE SPONGES WERE FOUND FULLY SEPARATED FROM THE CAP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE MISHANDLING DURING DISTRIBUTION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A NONCONFORMANCE 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

    IT WAS REPORTED THAT THE SPONGE WAS FOUND SEPARATED FROM EACH OF TWO (2) MINICAPS. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414204 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - GUANGZHOU NA GM1704102

    Patients

    Seq Age Sex Outcome Treatment
    1