BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR

    MDR report key: 21098873 · Received January 7, 2025

    Report

    Report Number
    3006260740-2024-08174
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    September 27, 2022
    Report Date
    April 6, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ZHAO Y, ZHAO Q, WEI W, YANG L, YU Y, ZHOU L, FU P, CUI T. ET AL (2023). PERCUTANEOUS SUPERIOR VENA CAVA PUNCTURE FOR HEMODIALYSIS CATHETER PLACEMENT. J VASC SURG VENOUS LYMPHAT DISORD. 2023 MAR;11(2):318-325. DOI: 10.1016/J.JVSV.2022.07.014. H10: AS THIS MALFUNCTION IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF FIVE FOR THIS EVENT. 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 CATHETER MALPOSITION ISSUES 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. H10: G3 H11: SECTION A THROUGH F: THE INFORMATION PROVIDE 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: ZHAO Y, ZHAO Q, WEI W, YANG L, YU Y, ZHOU L, FU P, CUI T. ET AL (2023). PERCUTANEOUS SUPERIOR VENA CAVA PUNCTURE FOR HEMODIALYSIS CATHETER PLACEMENT. J VASC SURG VENOUS LYMPHAT DISORD. 2023 MAR;11(2):318-325. DOI: 10.1016/J.JVSV.2022.07.014. 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. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE "JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS" TITLED, "PERCUTANEOUS SUPERIOR VENA CAVA PUNCTURE FOR HEMODIALYSIS CATHETER PLACEMENT", ONE PATIENT HAD CATHETER PIERCING THE CUPULA PLEURA FOLLOWED BY URGENT THORACOTOMY AND SURGICAL REPAIR FOR HEMOTHORAX, MILD CHEST PAIN WAS NOTED IN 37 CASES, CATHETER DYSFUNCTION DUE TO THROMBOSIS IN 66 PATIENTS, CATHETER MALPOSITIONING IN 5 CASE AND CATHETER-RELATED BLOOD STREAM INFECTION IN 6 CASES.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS" TITLED, "PERCUTANEOUS SUPERIOR VENA CAVA PUNCTURE FOR HEMODIALYSIS CATHETER PLACEMENT", ONE PATIENT HAD CATHETER PIERCING THE CUPULA PLEURA FOLLOWED BY URGENT THORACOTOMY AND SURGICAL REPAIR FOR HEMOTHORAX, MILD CHEST PAIN WAS NOTED IN 37 CASES, CATHETER DYSFUNCTION DUE TO THROMBOSIS IN 66 PATIENTS, CATHETER MALPOSITIONING IN 5 CASE AND CATHETER-RELATED BLOOD STREAM INFECTION IN 6 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834868 HEMOSTAR DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown