BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER

    MDR report key: 22860593 · Received August 21, 2025

    Report

    Report Number
    3006260740-2025-06024
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    January 27, 2019
    Report Date
    October 30, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: KATHRYN LARUSSO, GERALDINE SCHAACK, TIFFANY FUNG, KEVIN MCGREGOR, JUSTIN LONG, MARIE-PIER DUMAS ET AL. SHOULD YOU PICK THE PICC. PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE. JOURNAL OF PEDIATRIC SURGERY, 2019 MAY;54(5):999-1004. DOI: 10.1016/J.JPEDSURG.2019.01.052. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED CATHETER OCCLUSION, BREAK, DISLODGEMENT AND MIGRATION 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. B5, D1, D2, D4 (MEDICAL DEVICE CATALOG #), 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

    H11: KATHRYN LARUSSO, GERALDINE SCHAACK, TIFFANY FUNG, KEVIN MCGREGOR, JUSTIN LONG, MARIE-PIER DUMAS ET AL. SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE. JOURNAL OF PEDIATRIC SURGERY, 2019 MAY;54(5):999-1004. DOI: 10.1016/J.JPEDSURG.2019.01.052. 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 THE JOURNAL "JOURNAL OF PEDIATRIC SURGERY" ARTICLE TITLED, "SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE", THAT SOMETIME POST CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE BY USING BARD BROVIAC CATHETER TO EVALUATE AND COMPARE THE OUTCOMES OF PERIPHERALLY INSERTED CENTRAL CATHETER TO BROVIAC, PATIENT DEVELOPED WITH CATHETER OCCLUSION, BREAKAGE, DISLODGEMENT AND MIGRATION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL "JOURNAL OF PEDIATRIC SURGERY" ARTICLE TITLED, "SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE", THAT SOMETIME POST CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE BY USING BARD BROVIAC CATHETER TO EVALUATE AND COMPARE THE OUTCOMES OF PERIPHERALLY INSERTED CENTRAL CATHETER TO BROVIAC, PATIENT DEVELOPED WITH CATHETER OCCLUSION, BREAKAGE, DISLODGEMENT AND MIGRATION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418618 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