BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 17385528 · Received July 24, 2023

    Report

    Report Number
    1416980-2023-03749
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME: MINICAP TRANSFER SET (PREVIOUSLY SUBMITTED AS NI). D4: CATALOGUE #: 5C4483 (PREVIOUSLY SUBMITTED AS ASKU). D4: LOT #: H22K01075 (PREVIOUSLY SUBMITTED AS ASKU). D4: EXPIRATION DATE: 11/01/2027 (PREVIOUSLY SUBMITTED AS NI). D4: UNIQUE IDENTIFIER (UDI) #: (B)(4) (PREVIOUSLY SUBMITTED AS NI). G4: PMA/510K # OR BLA#: K192705 (PREVIOUSLY SUBMITTED AS NI). H4: DEVICE MANUFACTURE DATE: 11/01/2022 (PREVIOUSLY SUBMITTED AS NI). 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IODINE FROM THE MINICAP SPONGE WAS LEAKING INTO THE PERITONEAL DIALYSIS (PD) TRANSFER SET WHILE THE MINICAP WAS CONNECTED TO THE FEMALE CONNECTOR OF THE TRANSFER SET AND THE TWIST CLAMP WAS IN THE CLOSED POSITION. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿BETADINE SOLUTION WAS SEEN IN TUBING ON TRANSFER SET ONCE MINICAP ON AND TRANSFER SET WAS CLOSED¿. THIS WAS OBSERVED DURING USE OF THE DEVICES FOR 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
    536145 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H22K01075 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MINICAP