BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14548848 · Received May 31, 2022

    Report

    Report Number
    0001625425-2022-01014
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 17, 2022
    Report Date
    July 7, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 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

    PLASTIC CONNECTOR BETWEEN LINE AND EXTENSION SET CRACKED AND LEAKING. LOT#11401159 DATE OF DISCOVERY: MAY 17, 2022 THIS OCCURRED WHILE IN USE ON A PATIENT AND REQUIRED REMOVAL FROM THE PATIENT.

    Description of Event or Problem · 0

    PLASTIC CONNECTOR BETWEEN LINE AND EXTENSION SET CRACKED AND LEAKING. LOT#11401159 DATE OF DISCOVERY: (B)(6) 2022 THIS OCCURRED WHILE IN USE ON A PATIENT AND REQUIRED REMOVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2442264 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11401159 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O