BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETERS SHORT TERM

    MDR report key: 22105928 · Received May 29, 2025

    Report

    Report Number
    3004367028-2025-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 2, 2025
    Report Date
    October 10, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    MPB
    PMA / PMN Number
    K051730
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTO DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED LEAKAGE WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H11. H11: VANTIVE DOES NOT HAVE US REPORTING RESPONSIBILITY FOR PRODUCT CODE 101512.

    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 DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A GAMCATH (CATHETER SHORT TERM GDK), THE SECOND CIRCUIT WITH ACCESS WAS EXTREMELY NEGATIVE, WHICH ACCORDING TO THE REPORTER, CREATED A VACUUM IN THE ACCESS LINE. THE SITE HAD PUT A TEGO CONNECTOR (NON-VANTIVE DEVICE) ON THE CATHETER ENDS. IT WAS REPORTED THE VACUUM IN THE LINE CAUSED THE APPEARANCE OF AIR. THE SET AND TEGO CONNECTOR VALVES (NON-VANTIVE DEVICE) WERE REMOVED. IT WAS REPORTED THAT A HAIRLINE FRACTURE IN THE CATHETER WAS OBSERVED. ACCORDING TO THE REPORTER, SMALL DROPS OF BLOOD "NEARER THE WHITE GAM CATH HUB" WERE NOTED; HOWEVER, WHEN FLUSHING WITH SALINE, COULD NO LONGER BE SEEN. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS OBSERVED SOME SMALL DROPS OF BLOOD NEARER THE WHITE GAM CATH HUB ON THE WHITE TUBING COME OUT WHEN FLUSHED BUT WHEN IT WAS JUST SALINE THEY COULD NO LONGER SEE THE FLUID COMING OUT.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
    673195 CATHETERS SHORT TERM CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB VANTIVE US HEALTHCARE LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PRISMAFLEX ST60 SET.| TEGO CONNECTOR (NON-VANTIVE DEVICE).