BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO SAFETY VIAVALVE CATHETERS

    MDR report key: 11895732 · Received May 27, 2021

    Report

    Report Number
    3012307300-2021-05185
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 2, 2021
    Product Code
    PWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE USED VIAVALVE DEVICE, UNLOCKED WITHOUT CATHETER ASSEMBLY AND BLISTER PACKAGING, AND 24 UNOPENED, UNUSED SISTER SAMPLES WERE RETURNED FOR ANALYSIS. OF NOTE, IT WAS REPORTED THAT THE MEDICAL PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DESCRIPTIONS IN THE IFU, HOWEVER, IT SEEMED THE CUSTOMER WAS UNFAMILIAR WITH THE INDWELLING OPERATION OF SUCH PRODUCTS. BASED ON DEVICE ANALYSIS, THE COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING NONCONFORMANCE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS NOTED TO HAVE BLOOD LEAKING FROM IT EVEN THOUGH IT HAD A REVERSE FLOW PREVENTION VALVE. THE SITUATION WAS REMEDIED BY CHANGING THE PRODUCT TO ANOTHER ONE AND THEN INDWELLED IT TO THE PATIENT. THE MEDICAL PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DESCRIPTIONS IN THE IFU. HOWEVER, IT SEEMED THE CUSTOMER WAS UNFAMILIAR WITH THE INDWELLING OPERATION OF SUCH PRODUCTS. NO PATIENT INJURY NEITHER WAS THERE ANY REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789235 JELCO SAFETY VIAVALVE CATHETERS INTRAVASCULAR ADMINISTRATION SET PWO 3814163

    Patients

    Seq Age Sex Outcome Treatment
    1