BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11925126 · Received June 2, 2021

    Report

    Report Number
    0001625425-2021-00947
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    April 25, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR REVIEW. A FUNCTIONAL TEST FOUND LEAKAGE THROUGH A CRACK IN THE HUB, CONFIRMING THE COMPLAINT. CAPA C-2020-016 HAS BEEN INITIATED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. THE MOLDING PARAMETERS OF THESE HUBS WERE UPDATED TO MEET MANUFACTURERS SUGGESTED SETTINGS AND MOLD 501-05 CAVITY 4 HAD A NEW CORE PIN INSTALLED THAT CONTROLS ALL THE CRITICAL DIMENSIONS FOR THE INNER DIAMETER. THE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    THERE HAVE BEEN TWO OR THREE INSTANCES WHERE A FRESH PICC LESS THAN 48 HOURS HAD TO BE PULLED BECAUSE THERE WAS A CRACK AT THE END OF THE LINE (THE HUB). DRESSING WET AND FLUID NOTED TO BE LEAKING FROM CRACK IN HUB. NO ADVERSE REACTION WAS REPORTED. HOWEVER, INCREASE RISK OF INFECTION, SKIN BREAKDOWN, NEW PICC PLACEMENT, ADDITIONAL IV ATTEMPTS AND ADDED STRESS ON PATIENT IS A CONCERN. WE USE ICU MEDICAL EXTENSION TUBING NO END CAPS USED, TEGADERM AND STERI STRIPS TO SECURE LINE.

    Additional Manufacturer Narrative · 1

    SAMPLE INDICATED AS AVAILABLE FOR EVALUATION. FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 1

    THERE HAVE BEEN TWO OR THREE INSTANCES WHERE A FRESH PICC LESS THAN 48HRS HAD TO BE PULLED BECAUSE THERE WAS A CRACK AT THE END OF THE LINE (THE HUB). DRESSING WET AND FLUID NOTED TO BE LEAKING FROM CRACK IN HUB. NO ADVERSE REACTION WAS REPORTED. HOWEVER, INCREASE RISK OF INFECTION, SKIN BREAKDOWN, NEW PICC PLACEMENT, ADDITIONAL IV ATTEMPTS AND ADDED STRESS ON PATIENT IS A CONCERN. WE USE ICU MEDICAL EXTENSION TUBING NO END CAPS USED, TEGADERM AND STERI STRIPS TO SECURE LINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822728 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 384539 11321244 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other