BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 17404501 · Received July 27, 2023

    Report

    Report Number
    3015060232-2023-00008
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 27, 2023
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    FOZ
    UDI-DI
    00850030354211
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) (NURSE MANAGER, IV THERAPY SERVICES AT (B)(6) HOSPITAL) TEXTED THE AVI CLINICAL FIELD DIRECTOR ON (B)(6) 2023 TO NOTIFY HIM OF A LEAKING MIDLINE DEVICE. (B)(6) PROVIDED ADDITIONAL INFORMATION TO THE AVI COMPLAINTS TEAM VIA E-MAIL: THE MIDLINE WAS INSERTED ON (B)(6) 2023 FOR "ALL THINGS IV" DUE TO THE PATIENT'S POOR VENOUS ACCESS. NO POWER INJECTIONS WERE PERFORMED. A FEW CT SCANS WERE DONE, BUT WITHOUT CONTRAST. (B)(6) TEAM IS REQUIRED TO CHANGE THE NEEDLELESS CONNECTOR AND FLUSH THE DEVICE DURING EACH DRESSING CHANGE. DURING ONE OF THE DRESSING CHANGES, (B)(6) TEAM DISCOVERED A SMALL HOLE, VISIBLE TO THE HUMAN EYE, IN THE TUBING LOCATED "JUST AFTER THE CONNECTOR HUB." NOTE THAT THE HOLE WAS NOT IN THE HYDROMID MATERIAL. THE MIDLINE WAS REMOVED ON (B)(6) 2023 (DWELL TIME OF 14 DAYS). THE PATIENT DID NOT REQUIRE ANY FURTHER IV ACCESS SO THERE WAS NO IMPACT TO THE PATIENT. (B)(6) TEAM DID NOT TAKE ANY PHOTOS OF THE DEFECT. THE TUBING NOTED IS REFERRING TO THE CATHETER EXTENSION TUBE, WHICH IS MANUFACTURED BY CUTTING SECTIONS OF EXTENSION TUBE EXTRUSIONS (PURCHASED FROM AN APPROVED SUPPLIER AND INSPECTED PER AVI'S INTERNAL QUALITY INSPECTION PLAN) INTO 63MM LENGTH SECTIONS. THIS RESULTS IN A CLEAR, TECOTHANE TUBING THAT CONNECTS THE SUTURE WING TO THE LUER HUB. THE LOT NUMBER PROVIDED (11473239) IS ASSIGNED BY AVI'S APPROVED CONTRACT MANUFACTURER FOR KITTING. THIS FINISHED GOOD LOT CONTAINED CATHETERS FROM SIX DIFFERENT AVI CATHETER LOT NUMBERS: #01052302, #12222205, #01162306, #12132202, #01252308, AND #02162302. FOR THIS INVESTIGATION, ALL SIX LHRS WERE REVIEWED, AND NO DISCREPANCIES WERE IDENTIFIED THAT COULD POTENTIALLY IMPACT THE EXTENSION TUBES. SINCE THE DWELL TIME WAS 14 DAYS BEFORE THE DEFECT WAS FOUND AND IT WAS ACTIVELY BEING USED BY THE ACCESS TEAM, IT CAN BE CONCLUDED THAT THE EXTENSION TUBE DID NOT HAVE A HOLE UNTIL SOMETIME AFTER THE INSERTION OF THE DEVICE. WITHOUT PHOTOS OF THE DEFECT OR A RETURN OF THE DEVICE, AVI IS NOT ABLE TO DETERMINE A POTENTIAL ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A MIDLINE WITH A LEAK IN THE EXTENSION TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637795 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR INC. MID-141CM 11473239 00850030354211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other