BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 12193504 · Received July 19, 2021

    Report

    Report Number
    1416980-2021-04417
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    October 11, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 AND G4. D4: CATALOGUE #: WAS CHANGED FROM 5C4482 TO 5C4483. G4: PMA/510K # OR BLA #: WAS CHANGED FROM K152675 TO K192705. H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE CUSTOMER RETURNED A SAMPLE WITH PRODUCT CODE 5C4483 FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION NOTED THE FEMALE CONNECTOR WAS SEPARATED FROM THE 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 SEPARATION WAS DUE TO INADEQUATE SOLVENT APPLICATION DURING MANUFACTURING. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED FOR REPORTED LOT H20J29062 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE CONNECTOR SEPARATED FROM THE MAIN BODY OF A PERITONEAL DIALYSIS (PD) TRANSFER SET. THIS ISSUE OCCURRED DURING THE POSTOPERATIVE FLUSH AFTER THE TRANSFER SET WAS APPLIED TO THE PATIENT. TO RESOLVE THIS ISSUE, THE TRANSFER SET WAS REPLACED. THERE WAS NO 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
    1084073 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H20J29062

    Patients

    Seq Age Sex Outcome Treatment
    1