BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20658049 · Received November 11, 2024

    Report

    Report Number
    0001625425-2024-01135
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    April 26, 2023
    Report Date
    March 26, 2025
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ACCORDING TO THE CUSTOMER, THERE WERE NO SAMPLES AVAILABLE FOR REVIEW. ADDITIONALLY, THERE WAS NO VISUAL EVIDENCE PROVIDED TO SUPPORT THE ALLEGED COMPLAINT. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND THE COMPLAINT COULD NOT BE CONFIRMED. ESTABLISHING A ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTION FOR THE REPORTED ISSUE IS NOT POSSIBLE. ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11.

    Description of Event or Problem · 0

    DATE OF INSERTION ¿ (B)(6) 2023. 43 DAYS DWELL TIME. 3 DRESSING CHANGES. NURSE FOUND PICC LEAKING FROM CRACK ABOVE PURPLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974259 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS 384539 11454702 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown