BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPRT MRI ISP 8GR INT

    MDR report key: 8621140 · Received May 17, 2019

    Report

    Report Number
    3006260740-2019-01424
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 9, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741027512
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER 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 POWERPORT MRI ISP WITH GROSHONG CATHETER WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS INCONCLUSIVE FOR SUBCUTANEOUS LEAKAGE, AS THE PORT BODY AND CATHETER WERE PATENT TO INFUSION AND ASPIRATION AND INFUSION WITH NO LEAKS OBSERVED, BUT CERTAIN CLINICAL CONDITIONS NOT REPRODUCIBLE IN THE LABORATORY SETTING MAY CONTRIBUTE TO SUCH AN EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, FIBRIN SHEATH FORMATION OR CATHETER MALPOSITION RESULTING IN REDIRECTION OF FLOW OF INFUSATE COULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (PATIENT CODE + DESCRIPTION ) (RESULTS AND CONCLUSION). (EXPIRATION DATE: 10/2021).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SWELLING, HOWEVER, NO TREATMENT WAS PROVIDED TO TREAT THE SYMPTOMS. REPORTEDLY, AN ALLEGED SUBCUTANEOUS LEAK WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. (EXPIRATION DATE: 10/2021).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PATIENT EXPERIENCED PAIN AND SWELLING. IT WAS FURTHER REPORTED THAT AN ALLEGED SUBCUTANEOUS LEAKAGE WAS IDENTIFIED NEAR THE PORT SITE. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY POST REMOVAL AND REPLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414691 PPRT MRI ISP 8GR INT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS 9808560 RECV2867 00801741027512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention