BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER 26GA (1.9F) 0.65MM X 50CM

    MDR report key: 9758186 · Received February 26, 2020

    Report

    Report Number
    1625425-2020-00189
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 9, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    THREE REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE DEVICE. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. WITHOUT THE DEVICE OR ANY VISUAL EVIDENCE TO EVALUATE, THE COMPLAINT CANNOT BE CONFIRMED. IF ANY ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE THE COMPLAINT WILL BE RE-EVALUATED AS NEEDED.

    Description of Event or Problem · 0

    FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE IS INDICATED AS AVAILABLE FOR EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED. THE THIRD REQUEST FOR THE RETURN OF THE DEVICE WAS SENT ON 2/25/2020. A FOLLOW-UP REPORT WILL BE PROVIDED BY 3/25/2020.

    Description of Event or Problem · 1

    "WE HAD ANOTHER ARGON 1.9FR PICC LINE (PLACED BY THE NNICU TEAM) CRACK AT THE HUB WHILE THE INFANT WAS IN THE PICU. THE PRODUCT HAS BEEN SEQUESTERED AND IS IN MY OFFICE. NO DETECTABLE HARM.¿ -PER (B)(6). (B)(6) "OUR PEDIATRIC ICU NURSES HAVE REPORTED ANOTHER DEFECTIVE PRODUCT ISSUE WHILE USING THE ARGON #384232, 1.9FR PICC LINE. THE PRODUCT SHOWS A CRACK AT THE HUB. WE DO NOT HAVE THE LOT NUMBER TO PROVIDE TO YOU, HOWEVER I DO HAVE THE DEFECT SAMPLE IN MY OFFICE AVAILABLE FOR RETURN TO ARGON FOR EVALUATION. PLEASE PROVIDE A MAILER AND RGA SENT TO MY ATTENTION FOR THAT PURPOSE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223539 FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER 26GA (1.9F) 0.65MM X 50CM FIRST PICC FOZ ARGON MEDICAL DEVICES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1