BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 20184918 · Received September 10, 2024

    Report

    Report Number
    3015060232-2024-00018
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    LJS
    UDI-DI
    00862559000487
    PMA / PMN Number
    K193015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 REMOVED ON (B)(6) 2024 DUE TO A CRACKED AND LEAKING LUER. THE LINE WAS REPLACED WITHOUT ANY IMPACT ON THE PATIENT. THE INCIDENT WAS REPORTED TO AVI ON (B)(6) 2024, AND ON (B)(6) 2024, AVI DETERMINED THAT THE INCIDENT WAS NOT MDR REPORTABLE. THE LINE WAS RETURNED TO AVI AND EVALUATED ON 15AUG2024. DURING THE EVALUATION, AVI IDENTIFIED A BREAK IN THE CATHETER WALL THAT WAS NOT INITIALLY REPORTED BY THE USER. ON 05SEP2024, AVI DETERMINED THAT THE BREAK WAS MDR REPORTABLE. THE BREAK APPEARED AS A STRAIGHT, PERPENDICULAR CUT OR INCISION AT THE 5.1 CM MARK. THE SHAPE OF THE CUT, ALONG WITH THE ABSENCE OF MATERIAL DEFORMATION, SUGGESTS THAT IT WAS LIKELY CAUSED BY AN EXTERNAL FORCE RATHER THAN INTERNAL STRESS OR PRESSURE. THE INVESTIGATION INDICATES THAT THE LINE WAS DAMAGED BY THE SECUREMENT DEVICE AT SOME POINT DURING USE; HOWEVER, THE EXACT MECHANISM CAUSING THE CUT COULD NOT BE DETERMINED. IT WAS ALSO IDENTIFIED THAT THE SECUREMENT DEVICE USED WAS NOT THE ONE INCLUDED IN THE AVI PROCEDURE KIT. A REVIEW OF THE LOT HISTORY REVEALED NO NONCONFORMANCES ASSOCIATED WITH THE PRODUCTION LOT.

    Description of Event or Problem · 0

    OBSERVED A BREAK/CUT IN A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295229 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR. INC. PICC-142 CM 11560170 00862559000487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other