BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROMID

    MDR report key: 15517249 · Received September 30, 2022

    Report

    Report Number
    3015060232-2022-00002
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 23, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    FOZ
    UDI-DI
    00850030354020
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) (RN AT ALPHA 2 OMEGA HEALTHCARE) REPORTED TO AVI TWO CASES OF SUSPECTED DVT ON THE SAME DAY USING THE SAME LOT OF PRODUCT. AS A RESULT, AVI IS SUBMITTING TWO MDRS. (THIS MDR) IS BEING REPORTED FOR SUSPECTED DVT FOR A FEMALE PATIENT POST-MIDLINE PLACEMENT. A MIDLINE HAD BEEN INSERTED IN THE PATIENT'S LEFT UPPER ARM ON (B)(6) 2022 AT AN INPATIENT FACILITY AND REQUIRED REMOVAL ON THE SAME DAY. (B)(6) VIEWED THE ULTRASOUND REPORT AND WAS ABLE TO CONFIRM SUSPICION OF DVT. (B)(6) (RN, AVI CLINICAL FIELD DIRECTOR) INDICATED IT WAS LIKELY THE PATIENT GOT THE DVT BECAUSE THEY HAD ONE PREVIOUSLY, WHICH PREDISPOSES THE PATIENT TO ANOTHER DVT. (B)(6) DID CLARIFY THAT THE CATHETER HAD WHAT HE NOTED TO BE ABNORMAL SWELLING OF THE CATHETER ON INSERTION. BEFORE GETTING TO THE TAPER, HE HAD TROUBLE ADVANCING THE LINE THROUGH THE INTRODUCER. HE ALSO SAID THE PATIENT HAD TERMINAL CANCER. THE PATIENT HAD BEEN ON ANTICOAGULANTS BUT HAD BEEN TAKEN OFF, FOR REASONS UNKNOWN. THE PATIENT'S CLINICAL COURSE WAS UNINTERRUPTED BY THIS ISSUE. (B)(6) NOTED THAT HE HAD TRIED DIFFERENT METHODS FOR HYDRATION, RATHER THAN FOLLOW THE PROVIDED IFU. (B)(6) REINFORCED WITH (B)(6) THE IMPORTANCE OF UTILIZING THE CORRECT METHOD FOR HYDRATION. THE LOT HISTORY RECORDS FOR THE FOLLOWING LOTS WERE REVIEWED AND DID NOT REVEAL ANY ANOMALIES OR DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE: (B)(4).

    Description of Event or Problem · 0

    SUSPECTED DEEP VEIN THROMBOSIS (DVT) POST MIDLINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478962 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR INC. MID-141 11432076 00850030354020

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other