BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOINK ENDOSCOPIC MAKER

    MDR report key: 15037679 · Received July 18, 2022

    Report

    Report Number
    3004837686-2022-00006
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    April 11, 2022
    Report Date
    August 11, 2022
    Manufacturer
    MICRO-TECH(NANJING) CO.,LTD.
    Product Code
    NBG
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. HOWEVER, THE INCIDENT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE INCIDENT INVESTIGATION.

    Additional Manufacturer Narrative · 0

    1. DESCRIBE THE EVENT: ENDOINK LUER CAP WOULD NOT STAY ATTACHED TO SYRINGE. NEW DEVICE OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. UNFORTUNATELY DEVICE AND PACKAGING DISCARDED DURING CASE. THE CUSTOMER DID NOT PROVIDE THE PICTURE OF THE COMPLAINT, AND WE COMBINED THE HISTORIC COMPLAINTS FOR ANALYSIS. 2. CAUSE ANALYSIS: INFORMATION PROVIDED BASED ON HISTORICAL CUSTOMER COMPLAINTS, THE CUSTOMER CONNECTS THE NEEDLE TO ENDOINK SYRINGE. AFTER TURNING THE HANDLE, THE LUER LOCK SPINS AND CAN MOVE UP AND DOWN LEAVING A GAP BETWEEN THE ATTACHMENT AND THE SYRINGE. THIS IS CAUSED BY TOO MUCH FORCE WHEN INSTALLING THE INJECTION NEEDLE. WE SPECULATED THAT THE DOCTOR USED TOO MUCH FORCE TO REMOVE THE SYRINGE CAP AND THE SYRINGE CAP & THE LUER JOINT WERE REMOVED FROM THE SYRINGE 3. THE CORRECT WAY TO USE WE RECOMMEND: TAKE OUT THE SYRINGE, UNSCREW THE GUARD CAP OF THE SYRINGE, GENTLY ROTATE THE LUER JOINT OF THE INJECTION NEEDLE AND THE LUER JOINT OF THE SYRINGE, AND STOP ROTATING WHEN THE FORCE BECOMES OBVIOUSLY LARGE. 4.IN ORDER TO BETTER ENHANCE THE USER EXPERIENCE. OPTIMIZED SYRINGE LUER, ENDOINK HAS SWITCHED PRE-FILLED SYRINGE. THIS IMPROVEMENT CAN PREVENT SUCH PROBLEMS FROM HAPPENING AGAIN. WE WILL CONTINUE TO MONITOR TO MAKE SURE THIS ISSUE IS CLOSED.

    Description of Event or Problem · 0

    ON JULY 8, 2022. MICRO-TECH RECEIVED A 3500A REPORT NOTIFICATION FROM FDA. REPORT NUMBER:(B)(4). IT WAS REPORTED THAT ENDOINK LUER CAP WOULD NOT STAY ATTACHED TO SYRINGE. NEW DEVICE OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. UNFORTUNATELY DEVICE AND PACKAGING DISCARDED DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945122 ENDOINK ENDOSCOPIC MAKER MARKER, COLON NBG MICRO-TECH(NANJING) CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown