BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 28GA 1.2F X 25CM

    MDR report key: 18531873 · Received January 17, 2024

    Report

    Report Number
    0001625425-2024-00922
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    November 30, 2023
    Report Date
    September 4, 2024
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333221288
    PMA / PMN Number
    K091670
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE REPORTER INDICATED THEY WERE CALLED TO ASSESS BABY¿S PICC LINE DUE TO HUB WAS FILLING WITH TPN AND SMOF. DECISION WAS MADE TO CHANGE DRESSING AND EXTENSION. DURING DRESSING CHANGE AND AFTER EXTENSION CHANGE, PICC LINE WAS FOUND TO BE CRACKED AND WAS LEAKING. INSERTION DATE: (B)(6) 2023 (46 DAYS IN SITU). INTERVENTION: NNP WAS CALLED TO BEDSIDE AND PICC LINE WAS REMOVED, NEW PICC WILL BE INSERTED LATER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675724 L-CATH PICC S/L 28GA 1.2F X 25CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384540 11467300 00886333221288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other