BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13860404 · Received March 23, 2022

    Report

    Report Number
    0001625425-2022-00967
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 25, 2022
    Report Date
    April 25, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE SAMPLE WAS RETURNED FOR REVIEW. VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED A CRACK IN THE HUB WHICH COULD RESULT IN LEAKAGE. SEVERAL COMPLAINTS HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 HAS BEEN INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY UNDER INVESTIGATION. THE CAPA WILL IDENTIFY THE SPECIFIC CAUSES AND CORRECTIVE ACTIONS TO BE TAKEN. CAPA 2021-039 HAS BEEN INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY UNDER INVESTIGATION. THE CAPA WILL IDENTIFY THE SPECIFIC CAUSES AND CORRECTIVE ACTIONS TO BE TAKEN.

    Description of Event or Problem · 0

    PICC LINE PLACED AS REPLACEMENT PICC ON PER FORM (B)(6) PENN HOSPITAL #2 HUB CRACKED AND LEAKED AT 1755PM ON (B)(6) 2022. PER CUSTOMER APPROXIMATELY 23 HOURS AFTER INSERTION. PICC D/C¿ED. PIV PLACED BECAUSE PATIENT ON TPN, LIPIDS, AND ANTIBIOTICS THIS IS THE SAME PATIENT AS AGH WEST PENN HOSPITAL PER FORM #2. PATIENT HAD TWO PICC INSERTIONS WITHIN APPROXIMATELY 23 HOURS.

    Description of Event or Problem · 0

    PICC LINE PLACED AS REPLACEMENT PICC ON PER FORM AGH WEST PENN HOSPITAL #2 HUB CRACKED AND LEAKED AT 1755PM ON 3/13/2022. PER CUSTOMER APPROXIMATELY 23 HOURS AFTER INSERTION. PICC D/C¿ED. PIV PLACED BECAUSE PATIENT ON TPN, LIPIDS, AND ANTIBIOTICS THIS IS THE SAME PATIENT AS AGH WEST PENN HOSPITAL PER FORM #2. PATIENT HAD TWO PICC INSERTIONS WITHIN APPROXIMATELY 23 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365870 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 384539 11403016 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other