BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT CATHETER

    MDR report key: 20937881 · Received December 16, 2024

    Report

    Report Number
    3006260740-2024-07491
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    January 10, 2023
    Report Date
    November 26, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: JOONHO CHO, BYUNG HOON YOO, JIHWAN PARK, YUN HEE LIM, IN-JUNG JUN, KYE-MIN KIM (2023). SECONDARY MIGRATION OF A PRE-EXISTING CENTRAL VENOUS CATHETER DUE TO A SWAN-GANZ CATHETER INSERTION - A CASE REPORT. ANESTHESIA AND PAIN MEDICINE, 18(1):46-50. DOI: 10.17085/APM.22212. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED MIGRATION ISSUE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE CASE REPORT OF "ANESTHESIA & PAIN MEDICINE" TITLED, "SECONDARY MIGRATION OF A PRE-EXISTING CENTRAL VENOUS CATHETER DUE TO A SWAN-GANZ CATHETER INSERTION - A CASE REPORT", THAT SOMETIME LATER POST CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS MIGRATED DUE TO SWAN-GANZ CATHETER PLACEMENT. IT WAS FURTHER REPORTED THAT THE SURGEON MANUALLY ATTEMPTED TO REPOSITION THE CATHETER BUT IT WAS NOT SUCCESSFUL. REPORTEDLY, ONE DAY AFTER THE SWAN-GANZ CATHETER PLACEMENT, A GUIDEWIRE WAS INSERTED AND REPOSITIONED THE CATHETER TO TIP IN THE RIGHT ATRIUM. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381621 HEMOSPLIT CATHETER DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male