BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14304512 · Received May 6, 2022

    Report

    Report Number
    0001625425-2022-01001
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 3, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION CONFIRMED A CRACK IN THE LUER. SEVERAL COMPLAINTS FOR THIS PART NUMBER HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB 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

    DURING INSERTION, CLINICIAN PLACED PICC, REMOVED THE STYLET, ATTACHED FLUSH, OBTAINED AIR, AND THE HUB CRACKED. BECAUSE THE PEEL-A-AWAY SHEATH WAS STILL INDWELLING IN THE PATIENT THIS PICC WAS REMOVED AND A NEW PICC INSERTED.

    Description of Event or Problem · 0

    DURING INSERTION, CLINICIAN PLACED PICC, REMOVED THE STYLET, ATTACHED FLUSH, OBTAINED AIR, AND THE HUB CRACKED. BECAUSE THE PEEL-A-AWAY SHEATH WAS STILL INDWELLING IN THE PATIENT THIS PICC WAS REMOVED AND A NEW PICC INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473213 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11373440 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O