BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMID VENT COMPACT S

    MDR report key: 17341973 · Received July 18, 2023

    Report

    Report Number
    8040412-2023-00291
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    June 26, 2023
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), THE ACTUAL DEVICE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS "BASED ON THE INVESTIGATION CONDUCTED ON THE RETURNED SAMPLE, THE PAPER OF THE PACKAGE WAS FOUND TORN BEFORE USE. COMPLAINT WAS CONFIRMED AS REPORTED. HOWEVER COMPLAINT COULD NOT BE VERIFIED AS MANUFACTURING RELATED ISSUE. THIS PACKAGING TORN MAY HAPPEN DUE TO MISHANDLING OF THE PRODUCT. IN CURRENT MANUFACTURING PROCEDURE, 100% VISUAL INSPECTION IS DONE AT THE PACKING AREA. THUS, ANY TORN POUCH PRODUCT NOTICED WILL BE CULLED OUT DURING THIS PROCESS. IFU STATE THAT DO NOT USE IF PACKAGE IS BROKEN, AND STORAGE INSTRUCTION MENTION THAT DO NOT USE IF THE PRODUCT STERILIZATION BARRIER OR ITS PACKAGING IS COMPROMISED. IN CURRENT MANUFACTURING PROCEDURE, 100% LIGHT INSPECTION IS DONE DURING PACKING PROCESS. OPERATOR WHO CONDUCT THE INSPECTION WILL REJECT THE PRODUCT IF THERE IS ANY TORN PACKAGE. THERE IS VERY UNLIKELY FOR THE TORN PACKAGE PRODUCT WILL BE RELEASED FOR SHIPMENT. NO ABNORMALITY FOUND DURING THE PACKING PROCESS OF THIS PRODUCT. THERE IS NO MISHANDLING ISSUE DURING THE PACKING PROCESS. LRR (LOT REJECTION RATE) RECORD SHOWS THERE IS NO SIMILAR DEFECT FOR THIS PRODUCT FOUND DURING QA BUY OFF."

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE DOCTOR FOUND STERILE PACKAGE DAMAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE DOCTOR FOUND STERILE PACKAGE DAMAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840725 HUMID VENT COMPACT S CONDENSER, HEAT AND MOISTURE BYD TELEFLEX MEDICAL SDN. BHD. KMH22E0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown