BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 24718886 · Received March 30, 2026

    Report

    Report Number
    2314912-2026-00198
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Report Date
    April 21, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE: THE EVENT OCCURRED ON AN UNKNOWN DATE OF (B)(6) 2026. D10: CONCOMITANT PRODUCT: THE EVENT OCCURRED ON AN UNKNOWN DATE OF (B)(6) 2026. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G4: PMA/510K # OR BLA #: K192705 (PREVIOUSLY SUBMITTED AS NA). ADDITIONAL INFORMATION WAS ADDED TO H6 & H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED, AND NO ISSUES WERE OBSERVED. INTEGRITY OF SEAL SURFACE TEST WAS PERFORMED AND NO ISSUES OR LEAKS WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS LEAK A LEAK IN A MINICAP TRANSFER SET AND ¿ADAPTOR PARTS¿. THIS WAS FURTHER DESCRIBED AS THE LEAK OCCURRED ¿BETWEEN TITANIUM ADAPTER AND BEIGE CATHETER ADAPTER CONNECTER¿OF THE TRANSFER SET. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER WAS NOT EXCHANGED. 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
    32906 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA H24L06062 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown