BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER

    MDR report key: 22859945 · Received August 21, 2025

    Report

    Report Number
    3006260740-2025-06019
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    October 5, 2018
    Report Date
    November 26, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: VAN DEN BOSCH CH, VAN DER BRUGGEN JT, FRAKKING FNJ, TERWISSCHA VAN SCHELTINGA CEJ, VAN DE VEN CP, VAN GROTEL M, WELLENS LM, LOEFFEN YGT, FIOCCO M, WIJNEN MHWA. INCIDENCE, SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC ONCOLOGY PATIENTS; A SINGLE CENTER STUDY. J PEDIATR SURG. 2019 SEP;54(9):1894-1900. DOI: 10.1016/J.JPEDSURG.2018.10.054. 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 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

    H11: VAN DEN BOSCH CH, VAN DER BRUGGEN JT, FRAKKING FNJ, TERWISSCHA VAN SCHELTINGA CEJ, VAN DE VEN CP, VAN GROTEL M, WELLENS LM, LOEFFEN YGT, FIOCCO M, WIJNEN MHWA. INCIDENCE, SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC ONCOLOGY PATIENTS; A SINGLE CENTER STUDY. J PEDIATR SURG. 2019 SEP;54(9):1894-1900. DOI: 10.1016/J.JPEDSURG.2018.10.054. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: IT WAS REPORTED IN THE JOURNAL OF PEDIATRIC SURGERY OF ARTICLE TITLED, "INCIDENCE, SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC ONCOLOGY PATIENTS; A SINGLE CENTER STUDY", THAT SOMETIME POST CENTRAL LINE PLACEMENT PROCEDURE BY USING BARD BROVIAC/HICKMAN CATHETER TO EVALUATE THE SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC PATIENTS, OUT OF ONE HUNDRED TWENTY THREE PATIENTS, THIRTEEN OCCURRENCES OF DISLOCATION, TEN OCCURRENCES OF BREAKAGE, TEN OCCURRENCES OF DETACHMENT. IT WAS FURTHER REPORTED THAT TEN OCCURRENCES OF FAILURE OF PUNCTURING THE VEIN, ACCIDENTALLY PUNCTURING THE ARTERY AND NEGATIVE BLOOD RETURN AFTER INSERTION. THERE WAS NO REPORTED PATIENT INJURY. LABELLING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELLING OR USE RELATED ISSUE, A LABELLING REVIEW IS NOT REQUIRED. B5, D1, D2 (COMMON DEVICE NAME), D4 (MEDICAL DEVICE CATALOG #), G3, H6 (DEVICE). 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 THE JOURNAL OF PEDIATRIC SURGERY OF ARTICLE TITLED, "INCIDENCE, SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC ONCOLOGY PATIENTS; A SINGLE CENTER STUDY", THAT SOMETIME POST CENTRAL LINE PLACEMENT PROCEDURE BY USING BARD BROVIAC/HICKMAN CATHETER TO EVALUATE THE SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC PATIENTS, OUT OF ONE HUNDRED TWENTY THREE PATIENTS, THIRTEEN OCCURRENCES OF DISLOCATION, TEN OCCURRENCES OF BREAKAGE, TEN OCCURRENCES OF DETACHMENT. IT WAS FURTHER REPORTED THAT TEN OCCURRENCES OF FAILURE OF PUNCTURING THE VEIN, ACCIDENTALLY PUNCTURING THE ARTERY AND NEGATIVE BLOOD RETURN AFTER INSERTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL OF PEDIATRIC SURGERY OF ARTICLE TITLED, "INCIDENCE, SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC ONCOLOGY PATIENTS; A SINGLE CENTER STUDY", THAT SOMETIME POST CENTRAL LINE PLACEMENT PROCEDURE BY USING BARD BROVIAC/HICKMAN CATHETER TO EVALUATE THE SEVERITY AND OUTCOME OF CENTRAL LINE RELATED COMPLICATIONS IN PEDIATRIC PATIENTS, OUT OF ONE HUNDRED TWENTY THREE PATIENTS, THIRTEEN OCCURRENCES OF DISLOCATION, TEN OCCURRENCES OF BREAKAGE, TEN OCCURRENCES OF DETACHMENT. IT WAS FURTHER REPORTED THAT TEN OCCURRENCES OF FAILURE OF PUNCTURING THE VEIN, ACCIDENTALLY PUNCTURING THE ARTERY AND NEGATIVE BLOOD RETURN AFTER INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053660 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