BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINE 6FR D/L MI W/SCUFF

    MDR report key: 8135585 · Received December 5, 2018

    Report

    Report Number
    3006260740-2018-03480
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    October 30, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036606
    PMA / PMN Number
    K051417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED BLISTERS, BURNING, AND ITCHING THROUGHOUT THE BODY POST CHRONIC CATHETER PLACEMENT. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED MEDICATION FOR THE SYMPTOMS AND WAS HOSPITALIZED; HOWEVER, THE SYMPTOMS BECAME WORSE AND THE PATIENT WAS RECOMMENDED TO CALL HER PHYSICIAN IMMEDIATELY. THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975487 POWERLINE 6FR D/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700615 RECV0208 00801741036606

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R