BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 15406875 · Received September 12, 2022

    Report

    Report Number
    1416980-2022-04757
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 5C4483. D4: LOT #: WAS CHANGED FROM ASKU TO H21K15043. G4: PMA/510K # OR BLA #: WAS CHANGED FROM NI TO K192705. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: THE PATIENT WAS TREATED WITH ANTIBIOTICS. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE SILICONE TUBING WAS SEPARATED FROM THE DARK BLUE FEMALE CONNECTOR. MARKINGS WERE OBSERVED ON THE SILICONE TUBING INDICATING THE TUBING WAS POSITIONED ON THE FEMALE CONNECTOR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED, HOWEVER ASSEMBLY BETWEEN THE FEMALE CONNECTOR AND THE SILICONE TUBING IS A FRICTION FIT AND NOT A SOLVENT BOND. A STRONG TUG ON THE TUBING OR THE TWIST CLAMP COULD CAUSE A SEPARATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNSPECIFIED TRANSFER SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS 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
    2545066 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H21K15043 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown