BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERPORT MRI 8GS, INT. W SP, ATT S/L

    MDR report key: 19698081 · Received July 8, 2024

    Report

    Report Number
    3006260740-2024-03539
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    June 11, 2024
    Report Date
    December 5, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    UDI-DI
    00801741027246
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED AS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO MEDICAL RECORD WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS RECEIVED, AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS DEATH. H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6)1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 12/2025), G2, G3. H11: B5, D4 (MEDICAL DEVICE LOT NUMBER), H1, H6 (PATIENT). 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.

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS 01-JAN-1900 FOR THE MDR SUBMISSION REQUIREMENT. 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. NO PHOTOS WERE PROVIDED FOR REVIEW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THE MEDICAL RECORDS INDICATE A SECOND PORT WAS PLACED AFTER THE FIRST EXPERIENCED DIFFICULTY, AND THAT THE PORT ASPIRATED AND THEN FLUSHED EASILY. FLUOROSCOPY CONFIRMED THERE WERE NO KINKS IN THE PORT. THE REPORTED FRACTURE CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A 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: G3, H6 (METHOD). H11: D4 (UNIQUE IDENTIFIER (UDI) #), H6 (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY FRACTURED. REPORTEDLY, THE PORT WAS NOT REMOVED. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT PROCEDURE FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY FRACTURED. REPORTEDLY, THE PORT WAS NOT REMOVED. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210404 POWERPORT MRI 8GS, INT. W SP, ATT S/L PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 REHN2490 00801741027246

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Death