BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

    MDR report key: 10141070 · Received June 10, 2020

    Report

    Report Number
    1625425-2020-00350
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FOLLOW UP.

    Description of Event or Problem · 0

    FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE IS INDICATED AS AVAILABLE FOR EVALUATION. AS OF THE DATE OF THIS REPORT THE SAMPLE HAS NOT YET BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE SAMPLE IS RECEIVED AND REVIEWED.

    Description of Event or Problem · 1

    WHILE CHANGING THE PICC DRESSING PT STARTED BLEEDING THROUGH THE EXTERNAL PART OF THE PICC EXTENSION. THE EXTERNAL PORTION WAS CLAMPED BY RN AND PT WAS SENT TO IR FOR NEW INSERTION OF PICC AS PT IS TPN DEPENDENT. PRODUCT: BD L-CATH, GRM 16577, REF# 384539, LOT#11244867.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605182 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 26GA (1.9F) X 30CM 11244867 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1