BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER

    MDR report key: 22874105 · Received August 22, 2025

    Report

    Report Number
    3006260740-2025-06106
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 28, 2025
    Report Date
    November 27, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ZHANG JJ, NATARAJA RM, LYNCH A, BARNES R, FERGUSON P, PACILLI M. FACTORS AFFECTING MECHANICAL COMPLICATIONS OF CENTRAL VENOUS ACCESS DEVICES IN CHILDREN. PEDIATR SURG INT. 2022 JUL;38(7):1067-1073. DOI: 10.1007/S00383-022-05130-1. EPUB 2022 MAY 5. PMID: 35513517; PMCID: PMC9163013. 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. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FRACTURE, OBSTRUCTION OF FLOW AND DEVICE DISLODGED ISSUES AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. 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. D1, D2, D4 (MEDICAL DEVICE CATALOG NUMBER), G3 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

    ZHANG JJ, NATARAJA RM, LYNCH A, BARNES R, FERGUSON P, PACILLI M. FACTORS AFFECTING MECHANICAL COMPLICATIONS OF CENTRAL VENOUS ACCESS DEVICES IN CHILDREN. PEDIATR SURG INT. 2022 JUL;38(7):1067-1073. DOI: 10.1007/S00383-022-05130-1. EPUB 2022 MAY 5. PMID: 35513517; PMCID: PMC9163013. H11: 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. 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 "PEDIATRIC SURGERY INTERNATIONAL" TITLED, "FACTORS AFFECTING MECHANICAL COMPLICATIONS OF CENTRAL VENOUS ACCESS DEVICES IN CHILDREN", HICKMAN LINES AND ANGIODYNAMICS IMPLANTABLE PORT DEVICES WERE USED. INFECTIVE COMPLICATIONS CLABSI OCCURRED IN 34 CASES. IN ADDITION, THERE WERE A TOTAL OF 11 FRACTURE, 5 OCCLUSION AND 8 CATHETER DISLODGEMENT FOR HICKMAN CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "PEDIATRIC SURGERY INTERNATIONAL" TITLED, "FACTORS AFFECTING MECHANICAL COMPLICATIONS OF CENTRAL VENOUS ACCESS DEVICES IN CHILDREN", HICKMAN LINES AND ANGIODYNAMICS IMPLANTABLE PORT DEVICES WERE USED. INFECTIVE COMPLICATIONS CLABSI OCCURRED IN 34 CASES. IN ADDITION, THERE WERE A TOTAL OF 11 FRACTURE, 5 OCCLUSION AND 8 CATHETER DISLODGEMENT FOR HICKMAN CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439596 HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER LJS C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown