BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER

    MDR report key: 22494404 · Received July 14, 2025

    Report

    Report Number
    9612168-2025-00014
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 12, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00085412007403
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: TWO (2) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED AND NO ISSUES WERE OBSERVED. LEAK TESTING WAS PERFORMED AND NO ISSUES WERE OBSERVED. ASSEMBLY OF THE TITANIUM ADAPTER AND SLEEVE WAS PERFORMED TO VERIFY THE TITANIUM ADAPTER THREADS ONTO THE TITANIUM SLEEVE AND NO ISSUES WERE OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN TWO (2) TITANIUM ADAPTERS AND THE NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." THIS OCCURRED DURING USE OF THE DEVICE FOR 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
    774384 LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA 24F10H93 00085412007403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NON-VANTIVE CATHETER.