BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PICC D/L 20GA (2.BFR) PICC

    MDR report key: 12031742 · Received June 17, 2021

    Report

    Report Number
    MW5101959
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 2.6FR ARGON DL PICC PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2021 IN RIGHT FEMORAL VEIN. CATHETER TRIMMED TO 15.5CM WITH NO EXTERNAL LENGTH. ON (B)(6) 2021 AT 1500, CRACK FOUND ALONG RED HUB WHERE NEEDLELESS CONNECTOR ATTACHES. PICC REMOVED AND NEW PICC INSERTED TO CONTINUE TREATMENT. THIS IS THE 9TH EVENT (LUMEN CRACK) WITH THIS PRODUCT SINCE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911213 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911217 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911218 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911219 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911220 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911221 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911222 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911223 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041
    911224 L-CATH PICC D/L 20GA (2.BFR) PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARGON MEDICAL DEVICES INC. 384466 11316041

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DA Required Intervention