BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN

    MDR report key: 18234100 · Received November 29, 2023

    Report

    Report Number
    3014704491-2023-00773
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 4, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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 1 VIDEO AND 1 PHOTO, NO DEFECTIVE SAMPLE WAS RETURNED. 1)THE VIDEO SHOWS THAT THE EXTENSION TUBING IS LEAKING, AND THE FLOW RATE IS FAST. 2)THE PHOTO SHOWS THE LEAKAGE AREA OF THE EXTENSION TUBING CIRCLED WITH A RED PEN. 2. DHR/BHR REVIEW (LOT#3080067): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2023, AND PACKAGED AT R240 PACKAGE LINE IN MAY 2023. WORK ORDER QUANTITY WAS 198,000 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 BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3059864, 3083104, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE EXTENSION TUBING. SEE THE ATTACHED TEST REPORT. 4. CAUSE ANALYSIS: 1)THE FAST FLOW RATE OF THE LEAKAGE AT THE EXTENSION TUBING INDICATES THAT THERE IS A LARGE DAMAGE IN THE EXTENSION TUBING, WHICH CAN BE FOUND IN THEORY DURING THE EXHAUSTING PROCESS OF THE INDWELLING NEEDLE. 2) ANALYSIS FROM THE DAMAGE SITE OF THE EXTENSION TUBING: THE LOADING GRIPPING JAW WILL CONTACT THIS PART DURING THE PRODUCT ASSEMBLY PROCESS, THE PINCH CLAMP WILL ALSO CONTACT THIS PART, AND EXTERNAL FORCES (SUCH AS SCISSORS) MAY ALSO HURT THIS PART OF THE EXTENSION TUBING. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE VIDEO AND PHOTO RETURNED SHOW THAT THE EXTENSION TUBING IS LEAKING, AND THE FLOW RATE IS FAST. SINCE NO ABNORMALITIES ARE FOUND IN PROCESS AND RETAINED SAMPLE, THE SPECIFIC DAMAGE STATUS OF THE EXTENSION TUBING IS NOT CLEARLY IDENTIFIED, AND THE USAGE OF THE COMPLAINED SAMPLE IS UNKNOWN, SO THE ROOT CAUSE OF THE LEAKAGE OF THE EXTENSION TUBING CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO TRACK AND MONITOR SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN HAD DEFECTIVE/ DAMAGED TUBING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; ON NOVEMBER 4, 2023, A NURSE IN THE RESPIRATORY DEPARTMENT DISCOVERED A LEAK WHEN USING AN INDWELLING NEEDLE TO INFUSE A PATIENT, AND PROMPTLY REPLACED THE INDWELLING NEEDLE WITH A NEW ONE WITHOUT CAUSING ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940541 BD INTIMA-II Y 22GAX1.00IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080067 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown