BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PICC S/L 28GA (1.2F) 0.40MM X 25CM

    MDR report key: 21426806 · Received February 20, 2025

    Report

    Report Number
    0001625425-2025-00952
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 2, 2025
    Report Date
    December 3, 2025
    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
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    AFTER THOROUGHLY REVIEWING THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT, WE FOUND NO DEVIATIONS OR NON-CONFORMANCES. BASED ON THE PRODUCT EXPERIENCE REPORT, THE CUSTOMER INDICATED THE SAMPLE WAS AVAILABLE FOR RETURN. SEVERAL ATTEMPTS WERE MADE TO HAVE THE SAMPLE RETURNED. UNFORTUNATELY, NO SAMPLES HAVE BEEN RETURNED FOR EVALUATION. ADDITIONALLY, WE DID NOT RECEIVE ANY PHOTOGRAPHIC OR VISUAL EVIDENCE THAT WOULD HAVE ALLOWED US TO FURTHER REVIEW YOUR CONCERN. UNFORTUNATELY, WITHOUT THE NECESSARY EVIDENCE, WE ARE UNABLE TO CONDUCT A THOROUGH INVESTIGATION AT THIS TIME. AS A RESULT, DETERMINING THE ROOT CAUSE AND CORRECTIVE ACTION IS NOT FEASIBLE. IF SAMPLES BECOME AVAILABLE IN THE FUTURE, THE COMPLAINT CAN BE REOPENED FOR INVESTIGATION. ADDITIONAL INFORMATION PROVIDED IN H6 AND H11.

    Description of Event or Problem · 0

    BOTH LEAK AND OCCLUSION¿ ¿AT HUB¿ ¿LINE HAD TO BE PULLED¿ DURATION: ¿<2HRS¿ CONTINUOUS INFUSIONS: ¿NVN AT 2.8 CC, LIPIDS AT 0.2 CC¿ MEDICATIONS: ¿CAFFEINE¿ NOTES: ¿NEW PICC LINE PLACED. WHEN PICC DRESSING WAS ASSESSED 1 HOUR AFTER PLACEMENT, THE DRESSING WAS NOTED TO BE WET. LIP NOTIFIED. DRESSING WAS REMOVED, AND NVN/LIPIDS WERE NOTED TO BE LEAKING FROM CATHETER HUB. EXTENSION TUBING REMOVED AND REATTACHED, ENSURING TIGHT SECUREMENT. PICC REDRESSED. NO FURTHER LEAKING NOTED. LABS WERE DRAWN AT THE TIME OF THE LEAK, AND ALL LABS WERE STABLE. LINE ENDED UP LEAKING AGAIN AND WAS UNABLE TO FLUSH 2 HOURS LATER LINE HAD TO BE PULLED AND REPLACED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465801 L-CATH PICC S/L 28GA (1.2F) 0.40MM X 25CM CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARGON MEDICAL DEVICES 384540 11586169 00886333221288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention