BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 14410620 · Received May 16, 2022

    Report

    Report Number
    1416980-2022-02452
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Report Date
    June 3, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: WAS CHANGED FROM ASKU TO 5C4482. G4: PMA/510K # OR BLA #: WAS CHANGED FROM NI TO K152675. THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION NOTED THE FEMALE CONNECTOR SEPARATED FROM THE LIGHT BLUE MAIN BODY. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS RELATED TO INADEQUATE SOLVENT APPLICATION TO THE MAIN BODY DURING THE MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE PORTION) AND THE MAIN BODY (LIGHT BLUE PORTION) OF THE MINICAP TRANSFER SET. THE EVENT WAS FURTHER DESCRIBED AS ¿UNSCREWING BETWEEN THE DARK BLUE PORTION OF THE CATHETER AND THE LIGHT BLUE PORTION OF THE CATHETER¿. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092872 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown