BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN

    MDR report key: 14270454 · Received May 3, 2022

    Report

    Report Number
    0001625425-2022-00999
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    March 27, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209910
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION CONFIRMED A CRACK IN THE LUER. SEVERAL COMPLAINTS FOR THIS PART NUMBER HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB 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.

    Description of Event or Problem · 0

    ¿PATIENT WAS TRANSFERRED FROM DOCTOR¿S MODESTO THAT HAD AN ARGON 1.2FR L-CATH PICC LINE IN PLACE. THE PICC HUB CRACKED DURING THE PATIENTS STAY WITH US.¿ PICC PLACED ¿ (B)(6) 2022. DATE OF EVENT ¿ (B)(6) 2022. PICC WAS D/C¿ED. NEW PICC PLACED.

    Description of Event or Problem · 0

    ¿PATIENT WAS TRANSFERRED FROM DOCTOR¿S MODESTO THAT HAD AN ARGON 1.2FR L-CATH PICC LINE IN PLACE. THE PICC HUB CRACKED DURING THE PATIENTS STAY WITH US.¿ PICC PLACED ¿ (B)(6) 2022. DATE OF EVENT ¿ (B)(6) 2022. PICC WAS D/C¿ED. NEW PICC PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254274 L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN L-CATH PICC LJS ARGON MEDICAL DEVICES 384516 11387617 00886333209910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other