BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONEE NEEDLE FOR BLADDER INJECTION

    MDR report key: 21104191 · Received January 8, 2025

    Report

    Report Number
    9610711-2025-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 17, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FBK
    PMA / PMN Number
    K090217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE BEEN INFORMED ABOUT A DEFECT PRODUCT, "THE NEEDLE TIP FELL OFF" ON A BONEE PRODUCT. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND ANY OTHER COMPLAINT ON THE LOT NUMBER 9951990. THE PRODUCT REFERENCE NBI0351002 LOT NUMBER 9951990 WAS MANUFACTURED WITH AN INTERMEDIATE PRODUCT NBI03579 LOT NUMBER 9835194. THE INTERMEDIATE WAS MADE WITH A NEEDLE COMPONENT REFERENCE SS720670 LOT NUMBER 9525330. CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. ON 16TH JANUARY 2025, WE RECEIVED ONE USED SAMPLE. A VISUAL INSPECTION OF THE GLUE ON THE SAMPLE RECEIVED WITH A UV LAMP WAS CARRIED OUT AND CONFIRMED THE PRESENCE AND CORRECT DISTRIBUTION OF THE GLUE AT THE NEEDLE AND TUBE. IN ADDITION, ACCORDING TO OUR WORK INSTRUCTION (FSI), DURING THE MANUFACTURING PROCESS, ALL PIECES ARE CONTROLLED WITH AIR TEST THAT ALLOWS TO CHECK THE STICKING OF THE NEEDLE ON THE TUBE AND WHEN THERE IS A PROBLEM THE NEEDLE FALLS DURING THE TIME OF THE CONTROL. AT VISUAL EXAMINATION, WE CAN SEE A MARK/FOLD AT THE LEVEL OF THE NEEDLE WHICH MAY HAVE OCCURRED DURING PACKAGING AND THEREFORE WEAKENED THE GLUE. WITHOUT THE ORIGINAL PACKAGING, IT IS IMPOSSIBLE TO CONFIRM THIS ROOT CAUSE. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS ON THE LOT NUMBER 9951990. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE NEEDLE TIP FELL OFF IN THE SCOP/WORKING CHANNEL AND WAS FOUND THERE, NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321482 BONEE NEEDLE FOR BLADDER INJECTION ENDOSCOPIC NEEDLE, GENERAL-PURPOSE, SINGLE-USE FBK COLOPLAST A/S 9951990_NBI0351002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown