BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

    MDR report key: 20141700 · Received September 4, 2024

    Report

    Report Number
    0001625425-2024-01091
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209750
    PMA / PMN Number
    K972262
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE RECORDED RELATING TO THIS ISSUE. ACCORDING TO THE CUSTOMER, THERE WAS NO SAMPLE AVAILABLE FOR REVIEW. ACCORDING TO THE CUSTOMER, THERE WAS NO SAMPLE AVAILABLE FOR REVIEW. ADDITIONALLY, THERE WAS NO VISUAL EVIDENCE PROVIDED TO SUPPORT THE ALLEGED COMPLAINT. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THIS ISSUE WITH THIS LOT.

    Description of Event or Problem · 0

    THE CATHETER BROKE AT THE BASE NEAR THE LUER LOCK, AND A SMALL HOLE WAS SEEN WHERE THE SOLUTION WAS LEAKING (NPP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711672 FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM FIRST PICC S/L FOZ ARGON MEDICAL DEVICES 384232 11434460 00886333209750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown