BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15485296 · Received September 26, 2022

    Report

    Report Number
    0001625425-2022-01100
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    July 19, 2021
    Report Date
    October 22, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE OPENED CATHETER WAS RETURNED FOR REVIEW. VISUAL INSPECTION CONFIRMED A CRACK IN THE LUER THAT WOULD RESULT IN LEAKAGE. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    DATE PICC PLACED. (B)(6) 19 @1415. DATE OF PRODUCT EXPERIENCE. (B)(6) 22 @ 0100. SKU# 384539. LOT# 11410069. DESCRIBE EVENT. PLACED MIDLINE WITHOUT DIFFICULTY. THE NIGHT SHIFT NURSE NOTICED THE DRESSING WAS DAMP. UPON INVESTIGATION SHE FOUND THAT THERE WAS A CRACK IN THE HUB ANY HARM TO PATIENT? NOT DOCUMENTED IN INCIDENT REPORT FILED. IF SO, PLEASE DESCRIBE. WAS A NEW PIV PLACED FOR COMPLETION OF PRESCRIBED THERAPY? WAS A NEW PICC PLACED FOR COMPLETION OF PRESCRIBED THERAPY? YES . IS PRODUCT AVAILABLE FOR RETURN? YES.

    Description of Event or Problem · 0

    DATE PICC PLACED. 7/19 @1415 DATE OF PRODUCT EXPERIENCE. (B)(6) 2022 @ 0100. LOT# 11410069. DESCRIBE EVENT. PLACED MIDLINE WITHOUT DIFFICULTY. THE NIGHT SHIFT NURSE NOTICED THE DRESSING WAS DAMP. UPON INVESTIGATION SHE FOUND THAT THERE WAS A CRACK IN THE HUB ANY HARM TO PATIENT? NOT DOCUMENTED IN INCIDENT REPORT FILED. IF SO, PLEASE DESCRIBE. WAS A NEW PIV PLACED FOR COMPLETION OF PRESCRIBED THERAPY? WAS A NEW PICC PLACED FOR COMPLETION OF PRESCRIBED THERAPY? YES. IS PRODUCT AVAILABLE FOR RETURN? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2930463 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 11410069 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other