BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11670046 · Received April 15, 2021

    Report

    Report Number
    3006260740-2021-01304
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 19, 2021
    Report Date
    July 27, 2021
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION, A MEDICAL RECORD REVIEW WAS PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DIFFICULTY IN FLUSHING ISSUE. ACCORDING TO THE MEDICAL RECORD, APPROXIMATELY ELEVEN MONTHS AND TWENTY ONE DAYS POST PORT DEPLOYMENT, THE PORT WAS FOUND TO BE MALFUNCTIONED. AFTER A WEEK AND FOUR DAYS, THE PATIENT PRESENTED WITH CLOTTED ACCESS, PORPHYRIA AND NON-FUNCTIONAL LEFT CHEST WALL MEDIPORT. ON THE SAME DAY, AN ATTEMPT WAS MADE FOR PORT REMOVAL. UTILIZING BLUNT DISSECTION WITH A HEMOSTAT, THE PORT WAS EXPOSED. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED MIGRATION ISSUE AS THE EXACT CIRCUMSTANCES AT THE TIME OF REPORTED EVENT WAS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE 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: 06/2021), G3, H6 (DEVICE, METHOD). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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 SOME TIME POST PORT PLACEMENT, THE DEVICE ALLEGEDLY STOPPED FLUSHING AND SCOUT IMAGE REVEALED THAT THE PORT MIGRATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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. (EXPIRY DATE: 06/2021).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE DEVICE ALLEGEDLY MIGRATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572820 POWERPORT MRI 8GS, INT. W SP, ATT S/L PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 1878000 REAY0687 00801741027246

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention