BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14165080 · Received April 21, 2022

    Report

    Report Number
    0001625425-2022-00987
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 31, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS COULD NOT BE CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED. ACCORDING TO THE RETURNED PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE AVAILABLE FOR REVIEW. HOWEVER, THERE WAS A VIDEO PROVIDED OF THE REPORTED ISSUE. BASED ON THE VIDEO REVIEW, LEAKAGE WAS CONFIRMED AT THE HUB OF THE CATHETER. THE CUSTOMER STATED "NOTICED FINE CRACKS ON THE HUB". WITHOUT THE SAMPLE TO REVIEW, IT IS NOT POSSIBLE TO CONDUCT A THOROUGH INVESTIGATION OF THE ALLEGED CRACKS IN THE HUB. SEVERAL COMPLAINTS FOR THIS PART NUMBER HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 WAS INITIATED TO ADDRESS THIS ISSUE. THE CAPA IS CURRENTLY IN THE IMPLEMENTATION PHASE AND WILL EVALUATE THE CORRECTIVE ACTION IMPLEMENTATION FOR EFFECTIVENESS TO PREVENT A RECURRENCE OF THIS ISSUE. CAPA 2021-039 WAS INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY IN THE IMPLEMENTATION PHASE. THE CAPA WILL EVALUATE THE CORRECTIVE ACTION IMPLEMENTATION FOR EFFECTIVENESS TO PREVENT A RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 0

    NOTICED FINE CRACKS ON THE HUB - LEAKING NOTED 12-18HRS AFTER PROCEDURE. PICC HAD TO BE REMOVED.

    Description of Event or Problem · 0

    NOTICED FINE CRACKS ON THE HUB - LEAKING NOTED 12-18HRS AFTER PROCEDURE. PICC HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154183 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 384539 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other