BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NTIMA-II Y 24GAX0.75IN

    MDR report key: 17898312 · Received October 9, 2023

    Report

    Report Number
    3014704491-2023-00633
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 29, 2023
    Report Date
    November 14, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW (LOT#3052735): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 2) REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE STATUS AND COMPOSITION OF THE DIRT CANNOT BE DETERMINED. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTER IS FOUND, PLEASE SEE ATTACHMENT FOR THE CHECK REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE RETURNED, THE SOURCE OF THE DIRT IN THE INDWELLING NEEDLE CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO MONITOR SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6), 2023, WHEN THE NURSE OF THE INFECTIOUS DISEASE WARD OF OUR HOSPITAL WAS PREPARING TO USE THE CLOSED INTRAVENOUS INDWELLING NEEDLE PRODUCED BY SUZHOU BIDI MEDICAL EQUIPMENT CO., LTD. TO INDWELL THE PATIENT, SHE FOUND THAT THERE WAS DIRT IN THE INDWELLING NEEDLE AND MUST BE REPLACED WITH A NEW INDWELLING NEEDLE. THE ABOVE CONDITIONS AFFECT THE WORK OF MEDICAL STAFF AND THE TREATMENT OF PATIENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, WHEN THE NURSE OF THE INFECTIOUS DISEASE WARD OF OUR HOSPITAL WAS PREPARING TO USE THE CLOSED INTRAVENOUS INDWELLING NEEDLE PRODUCED BY SUZHOU BIDI MEDICAL EQUIPMENT CO., LTD. TO INDWELL THE PATIENT, SHE FOUND THAT THERE WAS DIRT IN THE INDWELLING NEEDLE AND MUST BE REPLACED WITH A NEW INDWELLING NEEDLE. THE ABOVE CONDITIONS AFFECT THE WORK OF MEDICAL STAFF AND THE TREATMENT OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710817 BD NTIMA-II Y 24GAX0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 3052735 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown