BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SMOOTH-FLO WITH DOUBLE SWIVEL,STERILE

    MDR report key: 14842965 · Received June 28, 2022

    Report

    Report Number
    8040412-2022-00173
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 15, 2022
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE MANUFACTURING SITE REPORTS "CHECKING THE PREVIOUS TREND FROM LOT REJECTION RATE (LRR) FOR THIS AFFECTED LOT, THERE IS NO FAILURE FOUND ON EXCESSIVE GLUE AS PER REPORTED. IN MANUFACTURING SITE, 100% INSPECTION AND LEAK TESTING WAS CONDUCTED TO THIS PRODUCT. THE DEFECTIVE PART WILL BE CULLED OUT AND REJECTED BEFORE RELEASED FOR SHIPMENT." WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE ADHESIVE OF THE PRODUCT STUCK OUT SO THAT THE JOINT DID NOT TURN SMOOTHLY". CLARIFICATION FOR INITIAL INFORMATION WAS RECEIVED BY THE CUSTOMER AND IT WAS REPORTED THAT THE "DEFECT IS THAT THE CONNECTION PIECE HAS EXTRA ADHESIVE PREVENTING IT FROM SETTING SECURELY". NO PATIENT INJURY WAS REPORTED. PATIENT CONDITION "UNKNOWN" AT TIME OF REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE ADHESIVE OF THE PRODUCT STUCK OUT SO THAT THE JOINT DID NOT TURN SMOOTHLY". CLARIFICATION FOR INITIAL INFORMATION WAS RECEIVED BY THE CUSTOMER AND IT WAS REPORTED THAT THE "DEFECT IS THAT THE CONNECTION PIECE HAS EXTRA ADHESIVE PREVENTING IT FROM SETTING SECURELY". NO PATIENT INJURY WAS REPORTED. PATIENT CONDITION "UNKNOWN" AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750164 HUDSON SMOOTH-FLO WITH DOUBLE SWIVEL,STERILE SET, TUBING AND SUPPORT,VENTILATOR BZO TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.