BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPOPICC

    MDR report key: 19352829 · Received May 20, 2024

    Report

    Report Number
    3015060232-2024-00011
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 21, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    LJS
    UDI-DI
    00850030354303
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED THAT THE PICC WAS INSERTED ON (B)(6) 2024 AND WAS REMOVED ON 2(B)(6) 2024 DUE TO INFILTRATION, SWELLING, AND SOME PAIN. THE LINE WAS REMOVED, AND THE BREAK IN THE CATHETER WAS IDENTIFIED APPROXIMATELY AT THE FEET OF A SECUREMENT DEVICE. THE LINE WAS RETURNED TO AVI FOR INVESTIGATION ALONG WITH THE SECUREMENT DEVICE. THE BREAK HAD THE APPEARANCE OF A CUT OR INCISION AT THE 2CM MARK, WHICH ALIGNED WITH THE ANCHOR TINES OF THE SECUREMENT DEVICE. THE INVESTIGATION SUGGESTS THAT THE LINE WAS DAMAGED BY THE SECUREMENT DEVICE AT SOME POINT DURING USE. DURING THE INVESTIGATION, IT WAS IDENTIFIED THAT THE SECUREMENT DEVICE UTILIZED WAS NOT THE DEVICE THAT IS INCLUDED IN THE AVI PROCEDURE KIT.

    Description of Event or Problem · 0

    REPORT OF A BREAK IN A PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856937 HYPOPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR INC. PICC-142 CM 01152405 00850030354303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other