BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15446431 · Received September 19, 2022

    Report

    Report Number
    0001625425-2022-01093
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 28, 2022
    Report Date
    November 3, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF SAMPLE WILL GET RETURNED FOR EVALUATION OR NOT. THERE WERE NO IMAGES OR VIDEOS PROVIDED FOR INVESTIGATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED OR SAMPLE IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. IT IS UNKNOWN IF THE SAMPLE WILL GET RETURNED OR NOT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE OPENED CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION CONFIRMED A CRACK IN THE LUER THAT WOULD RESULT IN LEAKAGE. SEVERAL COMPLAINTS FOR THIS PART NUMBER HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 WAS INITIATED TO ADDRESS THIS ISSUE. THE CAPA IS CURRENTLY IN THE IMPLEMENTATION PHASE AND WILL EVALUATE THE CORRECTIVE ACTION IMPLEMENTATION FOR EFFECTIVENESS TO PREVENT A RECURRENCE OF THIS ISSUE. CAPA 2021-039 WAS INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY IN THE IMPLEMENTATION PHASE. THE CAPA WILL EVALUATE THE CORRECTIVE ACTION IMPLEMENTATION FOR EFFECTIVENESS TO PREVENT A RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 0

    ¿LINE RN CALLED TO BEDSIDE DUE TO LINE LEAKING WHEN RN FLUSHING. LINE WAS JUST PLACED AT 0400 8/28 LOT NUMBER IS 11410069. LINE WAS REPAIRED AND REMOVED ON 8/29 WITH A NEW MIDLINE PLACED ON 8/29.¿

    Description of Event or Problem · 0

    ¿LINE RN CALLED TO BEDSIDE DUE TO LINE LEAKING WHEN RN FLUSHING. LINE WAS JUST PLACED AT 0400 (B)(6) LOT NUMBER IS 11410069. LINE WAS REPAIRED AND REMOVED ON (B)(6) WITH A NEW MIDLINE PLACED ON (B)(6).¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411922 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11410069 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other