BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 19952143 · Received August 9, 2024

    Report

    Report Number
    3015060232-2024-00017
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 9, 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 A BREAK IN A PICC LINE ON 11 JULY 2024. THE COMPLAINANT IDENTIFIED THAT THE LINE HAD BEEN IN PLACE FOR APPROXIMATELY 17 DAYS WHEN IT WAS REMOVED. THE PATIENT HAD BEEN RECEIVING DAILY INFUSIONS. THE TREATMENT WAS COMPLETED WITH A PERIPHERAL INTRAVENOUS (PIV) TUBE (7 DAYS). NO MANUFACTURING ISSUES WERE IDENTIFIED IN THE LOT HISTORY REVIEW. THE CATHETER WAS RETURNED FOR INVESTIGATION ON 09 AUG 2024. A BREAK IN THE CATHETER WAS IDENTIFIED AT THE 4.3CM MARK. NO OCCLUSIONS WERE DETECTED IN THE CATHETER. SIGNS OF KINKS IN THE CATHETER WERE IDENTIFIED AT THE 3.7CM, 4.3CM, AND 5.0 MARKS. THERE WERE INDICATIONS OF ABRASION OF THE CATHETER AT THE SITE OF THE BREAK THAT COULD HAVE CONTRIBUTED TO THE BREAK. THERE IS NO CLEAR INDICATION OF WHAT COULD HAVE CAUSED THE ABRASION. A ROOT CAUSE OF THE BREAK COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    REPORT OF A CATHETER BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493375 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