BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F

    MDR report key: 17332163 · Received July 17, 2023

    Report

    Report Number
    3006260740-2023-02997
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 21, 2023
    Report Date
    September 15, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741051692
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 09/2027) H11: 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. H3 OTHER TEXT : DEVICE PENDING RETURN.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE ELECTRONIC PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO SHOWS THE CLINICIAN HOLDING ONE HICKMAN SINGLE LUMEN CATHETER AND A C- SHAPED SPLIT WAS NOTED ON THE CATHETER BODY. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FRACTURE ISSUE. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED OBSTRUCTION OF FLOW ISSUE AS THE EXACT CIRCUMSTANCES AT THE TIME OF THE REPORTED EVENT WAS UNKNOWN. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: B5, D4 (EXPIRATION DATE: 09/2027), G3, H6 (METHOD) H11: H6 (DEVICE, RESULT, CONCLUSION) H11: 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A BREAK AT THIN/THICK JUNCTURE. IT WAS FURTHER REPORTED THAT RESISTANCE WAS ALLEGEDLY FELT/OCCLUSION ALARMS FROM PUMP PRIOR TO BREAKS. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A BREAK AT THIN/THICK JUNCTURE. IT WAS FURTHER REPORTED THAT RESISTANCE WAS ALLEGEDLY FELT/OCCLUSION ALARMS FROM PUMP PRIOR TO BREAKS. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616454 BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 0600060 HUGW0953 00801741051692

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown