BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15867059 · Received November 27, 2022

    Report

    Report Number
    0001625425-2022-01135
    Event Type
    Malfunction
    Date Received
    November 27, 2022
    Date of Event
    October 16, 2022
    Report Date
    December 20, 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

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. AFTER THREE NOTIFICATIONS, THERE HAS BEEN NO SAMPLE RETURNED FOR THIS COMPLAINT. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND ESTABLISHING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLES ARE RETURNED AT A FUTURE DATE, THESE COMPLAINTS WILL BE REOPENED FOR FURTHER EVALUATION AT THAT TIME.

    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.

    Description of Event or Problem · 0

    CRACKED HUB WITHIN FIRST DAY OF PLACEMENT.

    Description of Event or Problem · 0

    CRACKED HUB WITHIN FIRST DAY OF PLACEMENT: MEDWATCH #2622020000-2022-8018 ¿LOT NUMBER 11438264: 1.9FR CATH MIDLINE CRACKED AT HUB, NEW MIDLINE HAD TO BE PLACED. LINE HAD JUST BEEN PLACED. INFANT, MALE.¿ UPDATE EMAIL 10/27/2022 @ 0955 ¿IR 133123 LOT NUMBER 11438264: (B)(6) 2022 ¿ 1.9FR CATH MIDLINE CRACKED AT HUB, NEW MIDLINE HAD TO BE PLACED (B)(6) 2022. LINE HAD JUST BEEN PLACED ON (B)(6) 2022.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385768 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11438264 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other