BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 18670731 · Received February 8, 2024

    Report

    Report Number
    3015060232-2024-00004
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    January 13, 2024
    Report Date
    February 8, 2024
    Manufacturer
    ACCESS VASCULAR INC
    Product Code
    LJS
    PMA / PMN Number
    K193015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT INSERTED A HYDROPICC WITH A COLLEAGUE. THE PATIENT WAS OBESE AND HAD A HISTORY OF THROMBOSIS THAT MADE THE LEFT ARM UNUSABLE, SO THE LINE WAS INSERTED IN THE RIGHT ARM. NO WIRE WAS USED TO STIFFEN THE CATHETER. TWO WEEKS POST INSERTION, ON (B)(6) 2024, THE LINE WAS REPORTED AS LEAKING. THE CLINICIAN ONSITE REMOVED THE LINE. SHE FLUSHED THE LINE TO TEST IT AND FOUND IT TO BE LEAKING FROM A HOLE. THE CATHETER COULD NOT BE REPLACED DUE TO POOR ACCESS. ADDITIONAL INFORMATION PROVIDED BY THE COMPLAINANT: SHE ASSUMES THAT AT LEAST 2 DRESSING CHANGES WERE DONE DURING INSERTION. THE REMOVED LINE APPEARED TO BE KINKED IN 3 PLACES. THERE WERE NO DIFFICULTIES FLUSHING THE LINE. THERE WAS NO REPORT OF OCCLUSION OR DIFFICULTY FLUSHING. AN IMAGE WAS PROVIDED BY THE COMPLAINANT. SEE ATTACHMENT #1. THE CAUSE OF THE ALLEGED LEAKAGE CANNOT BE DETERMINED FROM THE IMAGE. THERE ARE SEVERAL INDENTATIONS THAT SUGGEST KINKING, BUT IF THEY ARE KINKS, IT CANNOT BE DETERMINED WHEN THEY OCCURRED: AT INSERTION, DURING USE, OR UPON REMOVAL. THE REPORTER INITIALLY INDICATED THAT THE LINE WAS AVAILABLE FOR RETURN TO AVI FOR FURTHER INVESTIGATION. HOWEVER, AFTER AVI PROVIDED INSTRUCTIONS AND A RETURN LABEL, THE CUSTOMER FAILED TO SEND BACK THE DEVICE AFTER THREE ADDITIONAL REQUESTS ON 26JAN2024, 30JAN2024, AND 02FEB2024. DURING THESE ATTEMPTS, AVI ALSO REQUESTED ADDITIONAL INFORMATION (LOT NUMBER, KIT TYPE, ETC.) TO AID WITH THE INVESTIGATION. THE COMPLAINANT DID NOT PROVIDE ANY MORE DETAILS. WITHOUT LOT INFORMATION OR RETURN OF THE DEVICE, AVI IS UNABLE TO INVESTIGATE FURTHER OR DETERMINE ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A TEAR IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905860 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR INC HYDROPICC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other