BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS

    MDR report key: 10086706 · Received May 26, 2020

    Report

    Report Number
    1036844-2020-00160
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 8, 2020
    Report Date
    May 11, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). IT WAS REPORTED "PICC WAS PLACED ON 5/8/20 AND CONFIRMED WITH VPS BBE. ON SUBSEQUENT CHEST X-RAY, RADIOLOGY DETERMINED TIP POSITION WAS 4 CM DEEP". NO SAMPLE OR CASE DATA WERE RETURNED FOR REVIEW. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. A PROBABLE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION WILL BE TAKEN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE NURSE REPORTS THAT THE PICC WAS PLACED ON 5/8/20 AND CONFIRMED WITH VPS BBE. ON SUBSEQUENT CHEST X-RAY, RADIOLOGY DETERMINED TIP POSITION WAS 4 CM DEEP. CATHETER WAS PULLED BACK AND THEN REPEAT X-RAY SHOWED CATHETER TIP AT CAJ.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTS THAT THE PICC WAS PLACED ON (B)(6) 2020 AND CONFIRMED WITH VPS BBE. ON SUBSEQUENT CHEST X-RAY, RADIOLOGY DETERMINED TIP POSITION WAS 4 CM DEEP. CATHETER WAS PULLED BACK AND THEN REPEAT X-RAY SHOWED CATHETER TIP AT CAJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551914 ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS INTRODUCER, CATHETER DYB ARROW INTERNATIONAL INC. 23F19G0114

    Patients

    Seq Age Sex Outcome Treatment
    1