BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER

    MDR report key: 22859950 · Received August 21, 2025

    Report

    Report Number
    3006260740-2025-06020
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    October 5, 2018
    Report Date
    September 15, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    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. 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 PNEUMOTHORAX, HEMOTHORAX, HEMATOMA, UNSPECIFIED INFECTION, THROMBOSIS, CARDIAC ARRHYTHMIA AND BLEEDING AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. FURTHERMORE, THE CLINICAL CONDITIONS ALLEGED IN THE COMPLAINT 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. D1, D2, D4 (UNIQUE IDENTIFIER (UDI) #), G3. 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

    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. 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 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.

    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. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053665 UNKNOWN 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 Required Intervention