BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPLIT CATHETER

    MDR report key: 20996511 · Received December 21, 2024

    Report

    Report Number
    3006260740-2024-07644
    Event Type
    Injury
    Date Received
    December 21, 2024
    Date of Event
    June 8, 2018
    Report Date
    January 29, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: LAURA LABRIOLA, BENJAMIN SERONT, RALPH CROTT, PAULINE BORCEUX, FRANK HAMMER, AND MICHEL JADOUL (2018). SUPERIOR VENA CAVA STENOSIS IN HEMODIALYSIS PATIENTS WITH A TUNNELED CUFFED CATHETER: PREVALENCE AND RISK FACTORS. JOURNAL OF NEPHROLOGY, DIALYSIS AND TRANSPLANTATION, 33(12): 2227-2233. DOI: 10.1093/NDT/GFY150. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    H10: LAURA LABRIOLA, BENJAMIN SERONT, RALPH CROTT, PAULINE BORCEUX, FRANK HAMMER, AND MICHEL JADOUL (2018). SUPERIOR VENA CAVA STENOSIS IN HEMODIALYSIS PATIENTS WITH A TUNNELED CUFFED CATHETER: PREVALENCE AND RISK FACTORS. JOURNAL OF NEPHROLOGY, DIALYSIS AND TRANSPLANTATION, 33(12): 2227-2233. DOI: 10.1093/NDT/GFY150. 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 STENOSIS ISSUE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. FURTHERMORE, THE CLINICAL CONDITION ALLEGED IN THE REPORTED EVENT CANNOT BE CONFIRMED. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE 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 "JOURNAL OF NEPHROLOGY, DIALYSIS AND TRANSPLANTATION" TITLED "SUPERIOR VENA CAVA STENOSIS IN HEMODIALYSIS PATIENTS WITH A TUNNELED CUFFED CATHETER: PREVALENCE AND RISK FACTORS", THAT SOMETIME POST A TUNNELED DIALYSIS CATHETER PLACEMENT, OUT OF EIGHT-FIVE PATIENTS, SEVEN PATIENTS ALLEGEDLY EXPERIENCED SUPERIOR VENA CAVA STENOSIS. THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE "JOURNAL OF NEPHROLOGY, DIALYSIS AND TRANSPLANTATION" TITLED "SUPERIOR VENA CAVA STENOSIS IN HEMODIALYSIS PATIENTS WITH A TUNNELED CUFFED CATHETER: PREVALENCE AND RISK FACTORS", THAT SOMETIME POST A TUNNELED DIALYSIS CATHETER PLACEMENT, OUT OF EIGHT-FIVE PATIENTS, SEVEN PATIENTS ALLEGEDLY EXPERIENCED SUPERIOR VENA CAVA STENOSIS. THE CURRENT STATUS OF THE PATIENTS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355547 HEMOSPLIT CATHETER DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention