BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 12933663 · Received December 6, 2021

    Report

    Report Number
    3015060232-2021-00005
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    August 2, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00862559000425
    PMA / PMN Number
    K193015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LOT HISTORY RECORD FOR LOT #03042101, INCLUDING LOT RELEASE TEST DATA, WAS PERFORMED, WHICH DID NOT REVEAL ANY ANOMALIES THAT COULD BE ATTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PATIENT'S THIRD VISIT: "PATIENT HAD THE FOLLOWING: LEFT BRACHIAL VEINS-ACUTE THROMBUS, PICC LINE: PARTIAL COMPRESSION:NORMAL PHASIC FLOW. LEFT ULNAR VEINS: ACUTE THROMBUS, PICC LINE: NO COMPRESSION LEFT BASILIC VEINS: UPPER ARM, ACUTE THROMBUS, PICC LINE, NO COMPRESSION LEFT CEPHALIC VEIN: UPPER ARM, ACUTE THROMBUS: NO COMPRESSION LEFT CEPHALIC VEIN: FOREARM: ACUTE THROMBUS: NO COMPRESSION [THE PHYSICIAN] WAS NOTIFIED THE SAME DAY AS EVENT. [THE PHYSICIAN] VERIFIED RESULTS. PATIENT WAS PLACED ON ANTICOAGULATION BY ATTENDING. PATIENT IS ASYMPTOMATIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830774 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR, INC. PICC-142S 03042101 00862559000425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other