BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 16116034 · Received January 6, 2023

    Report

    Report Number
    1416980-2022-07289
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H4, H6 AND H10. 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

    CORRECTION MADE TO D4: LOT #: H21K03031 (PREVIOUSLY SUBMITTED AS H22B21105). CORRECTION MADE TO D4: EXPIRATION DATE: 11/03/2026 (PREVIOUSLY SUBMITTED AS 02/21/2027). CORRECTION MADE TO H4: DEVICE MANUFACTURE DATE: 11/03/2021 (PREVIOUSLY SUBMITTED AS 02/21/2022). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED 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 · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TWIST CLAMP OF A MINICAP EXTENDED LIFE PD TRANSFER SET APPEARED TO HAVE UNSPECIFIED DAMAGE. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. IT WAS FURTHER REPORTED THAT THERE "MIGHT BE FLUID PATH BLOCKAGE". 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
    1565830 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H21K03031 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown