BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ HUBER 22G X 25MM WITH Y-SITE

    MDR report key: 8341214 · Received February 14, 2019

    Report

    Report Number
    3006260740-2019-00271
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Report Date
    February 14, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741089275
    PMA / PMN Number
    K071846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING INFUSION SET WAS INCONCLUSIVE BECAUSE THE IMPLICATED DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 22GA X 1¿ EZ HUBER SAFETY INFUSION SET. THE SAMPLE WAS RECEIVED IN ITS ORIGINAL SEALED PACKAGING. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE USING A 12ML SYRINGE REVEALED THE SAMPLE TO BE PATENT TO INFUSION AND ASPIRATION WITH NO OBSERVED LEAKS. NO LEAKS WERE OBSERVED DURING SUSTAINED (>15 SECONDS) HYDRAULIC PRESSURIZATION OF THE SAMPLE. MICROSCOPIC INSPECTION OF THE SAMPLE WAS UNREMARKABLE. NO DEFICIENCIES WERE DISCOVERED DURING EVALUATION OF THE RETURNED SAMPLE; HOWEVER, THE SEALED AND UNUSED STATE OF THE RETURNED SAMPLE INDICATED THAT IT WAS NOT THE DEVICE IMPLICATED BY THE COMPLAINANT. CONSEQUENTLY THIS COMPLAINT IS INCONCLUSIVE AT THIS TIME. A LOT HISTORY REVIEW (LHR) OF RECT0218 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EZ HUBER NEEDLE LEAKED AT THE Y-SITE ONTO THE PATIENT DURING THE ADMINISTRATION OF CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135251 EZ HUBER 22G X 25MM WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A RECT0218 00801741089275

    Patients

    Seq Age Sex Outcome Treatment
    1