BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F

    MDR report key: 17266377 · Received July 6, 2023

    Report

    Report Number
    3006260740-2023-02803
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 12, 2023
    Report Date
    March 7, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. EXPIRY DATE: 09/2027. : 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. 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: ONE SEALED BROVIAC 4.2F S/L CATHETER KIT WAS RECEIVED FOR EVALUATION. GROSS VISUAL EVALUATIONS WERE PERFORMED. THE SAMPLE APPEARED TO BE CLEAN AND NO OTHER ANOMALIES WERE NOTED. THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FRACTURE ISSUES. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 09/2027), G3, H6 (METHOD) H11: H6 (DEVICE, RESULT, CONCLUSION) H11: 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.

    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: ONLY ONE DEVICE WAS INVOLVED IN THIS REPORTABLE EVENT AT THE USER FACILITY. ADDITIONAL UNUSED LOT SAMPLES FROM THE SAME LOT/PRODUCT CATALOG NUMBER WERE RETURNED FROM THE CUSTOMER FOR EVALUATION AND INVESTIGATION OF THIS EVENT. THE ORIGINAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 09/2027), G3 H11: H6 (RESULT, CONCLUSION) H11: 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    HOLD FOR JF 7.6. IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN AT THE THIN/THICK JUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931112 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 NA Unknown