BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Y-SITE BLUE VALVE

    MDR report key: 10215273 · Received June 30, 2020

    Report

    Report Number
    9616066-2020-02060
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 2, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION, THE FOLLOWING WAS CONCLUDED: PER PICTURES PROVIDED BY THE CUSTOMER (IMAGE 1) THE LEAK FAILURE MODE CAUSED BY THE DAMAGED VALVE WAS OBSERVED AND SINCE NO LOT NUMBER REPORTED DHR REVIEW WAS NOT PERFORMED. A GEMBA WALK WITH THE MOLDING TEAM WAS PERFORMED TO REVIEW THE PROCESS OF THE VALVE FOR THE MODEL 8100-027. SINCE NO LOT WAS REPORTED WAS NOT ABLE TO CONFIRM IF THE VALVE WAS MANUFACTURED BY THE INTERNAL MOLDING TEAM OR BY A SUPPLIER, HOWEVER, ACCORDING WITH THE MOLDING TEAM, A POTENTIAL CAUSE OF THE LEAK COULD BE RELATED TO A POSSIBLE SHORT SHOT DUE TO AN OVER MOLDING IN THE VALVE, WHEN THE VALVES ARE MOLDED BY THE INTERNAL TEAM ARE TESTED UNDER THE ¿ ATP METODO DE MEDICION PARA VALVULAS¿ DIR 10000264146, TO DETECT ANY POSSIBLE SHORT SHOT DURING THE MANUFACTURING, ALSO, A SHORT SHOT COULD BE DETECTED DURING THE MAX PRESSURE TEST PER THE CURRENT PROCEDURE ¿ ATP-140 FUNCTIONAL TEST MAXIMUS NEEDLELESS¿ DIR 10000249358 DURING THE MANUFACTURING OF 8100-027. SINCE NO LOT WAS REPORTED, THE DHR WAS NOT PERFORMED AND WAS NOT ABLE TO CONFIRM IF THE VALVE WAS MANUFACTURED BY THE INTERNAL MOLDING TEAM OR BY A SUPPLIER, THE PROCESS REVISION, NO TREND FOR THIS FAILURE MODE WAS FOUND IN THE MANUFACTURING PROCESS, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINATE. AS IMMEDIATE/CONTAINMENT ACTION A SUPPLIER NOTIFICATION WAS SUBMITTED ON OCTOBER 14TH,2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD Y-SITE BLUE VALVE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: Y-SITE BLUE VALVE MOLDING ISSUE CAUSING Y-SITE LEAK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD Y-SITE BLUE VALVE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: Y-SITE BLUE VALVE MOLDING ISSUE CAUSING Y-SITE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679499 UNSPECIFIED BD Y-SITE BLUE VALVE Y-SITE VALVE FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other