BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 18414149 · Received December 28, 2023

    Report

    Report Number
    3014704491-2023-00850
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    September 2, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    NA
    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. THE CUSTOMER RETURNED 3 PHOTOS, BUT DID NOT RETURN DEFECTIVE SAMPLE. THE PHOTOS SHOW: THE SKU IS 383028, THERE IS A SCAR IN THE MIDDLE OF THE EXTENSION TUBING. 2. DHR/BHR REVIEW(LOT#3017073): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN FEBRUARY 2023, AND PACKAGED AT R240 PACKAGE LINE IN FEBRUARY 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. 4)THE EXTENSION TUBING BATCH USED IN THIS BATCH OF PRODUCTS IS 3012853, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 5)THE PINCH CLAMP BATCH USED IN THIS BATCH OF PRODUCTS IS 2335839, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN, THE EXTENSION TUBING AND THE CLAMPING PARTS OF THE PINCH CLAMP ARE CHECKED, NO ABNORMALITY IS FOUND. THEN, THE SAMPLE IS CARRIED OUT FOR THE PINCH CLAMP SEALING PRESSURE TEST (TEST PROCESS: THE EXTENSION TUBING IS CLAMPED IN THE SAME POSITION FOR MORE THAN 64 TIMES, AND THEN KEPT IN THE CLAMPED STATE UNDER 800MM PRESSURE DEVICE FOR 3 DAYS), AND NO LEAKAGE IS FOUND AT THE EXTENSION TUBING. PLEASE SEE ATTACHMENT FOR THE TEST 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 SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOW THAT THERE IS A SCAR IN THE MIDDLE OF THE EXTENSION TUBING. AS THE DEFECTIVE SAMPLE IS NOT RECEIVED, THE SPECIFIC DAMAGE STATUS OF THE EXTENSION TUBING AND THE CLAMPING PARTS OF THE PINCH CLAMP CANNOT BE CONFIRMED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, SO THE ROOT CAUSE OF THE DAMAGE AND LEAKAGE OF THE EXTENSION TUBING CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC WAS DIFFICULT TO CLAMP THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO OUR PEDIATRIC WARD FOR PNEUMONIA. THE NURSE PUNCTURED THE CHILD'S INDWELLING NEEDLE ON (B)(6) 2023 AT 1:00 P.M. EVERYTHING WAS FINE.ON (B)(6) 2023 AT 9:27 A.M., WHILE ADMINISTERING IV FLUIDS, IT WAS DISCOVERED THAT THE INDWELLING NEEDLE'S STOPCOCK CLIP CLOSURE HAD BROKEN AND FLUID WAS LEAKING. AFTER CALMING THE CHILD AND FAMILY, THE NURSE REMOVED THE INDWELLING NEEDLE AND RE-PUNCTURED A NEW ONE TO COMPLETE THE INFUSION FOR THE CHILD. AFTERWARDS, THE MANUFACTURER'S SUZHOU BIDI MEDICAL DEVICES CO. SALESPERSON WAS CONTACTED, AND THE SALESPERSON RETRIEVED THE INDWELLING NEEDLE ON SEPTEMBER 5, 2023, AND SENT IT BACK TO THE FACTORY FOR TESTING. THE SECOND PUNCTURE, INCREASING THE CHILD'S PAIN AND THE POSSIBILITY OF DOCTOR-PATIENT CONFLICT, WAS REPORTED AS AN ADVERSE REACTION. GOOGLE TRANSLATION: THE PATIENT WAS HOSPITALIZED IN THE PEDIATRIC WARD OF OUR HOSPITAL DUE TO PNEUMONIA. THE NURSE PUNCTURED AND INSERTED THE NEEDLE INTO THE CHILD AT 1 PM ON (B)(6) 2023, AND EVERYTHING WAS NORMAL. AT 9:27 A.M. ON (B)(6) 2023, DURING INTRAVENOUS INFUSION, IT WAS DISCOVERED THAT THE CLAMP OF THE INDWELLING NEEDLE'S FLOW-STOP CLAMP WAS BROKEN AND THE FLUID LEAKED OUT. AFTER THE NURSE COMFORTED THE CHILD AND HIS FAMILY, HE REMOVED THE INDWELLING NEEDLE AND PUNCTURED A NEW ONE TO COMPLETE THE INFUSION FOR THE CHILD. AFTERWARDS, I CONTACTED THE SALESPERSON OF THE MANUFACTURER, SUZHOU BIDI MEDICAL EQUIPMENT CO., LTD., WHO TOOK THE INDWELLING NEEDLE BACK ON SEPTEMBER 5, 2023 AND SENT IT BACK TO THE FACTORY FOR TESTING. A SECOND PUNCTURE INCREASES THE PAIN OF THE CHILD AND INCREASES THE POSSIBILITY OF CONFLICTS BETWEEN DOCTORS AND PATIENTS, SO ADVERSE REACTIONS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312147 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3017073 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown