BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 18069636 · Received November 3, 2023

    Report

    Report Number
    3014704491-2023-00711
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 17, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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 2 PHOTOS, NO ACTUAL SAMPLES. PHOTOS SHOW: THE SKU IS 383012, THE BATCH CODE IS 2216532, THE SLEEVE STOPPER OF THE PRN IS FALLEN OFF. 2. DHR/BHR REVIEW(LOT#2216532): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2022, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2022. 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 PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 2201532, 2201533, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT BATCH FOR RELEVANT FUNCTIONAL TESTING: 1)45PSI LEAKAGE TEST IS PERFORMED, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE PRN. 2)PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING) IS CARRIED OUT, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 4. SKU# 383012 IS AN INTIMA II PRODUCT (PVC EXTENSION TUBING, Y CONNECTION SITE). THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE FORCING OF LIQUID THROUGH THE PRODUCT DURING ENHANCED CT MAY CAUSE DAMAGE TO THE PRN OR OTHER PARTS OF THE PRODUCT. 5. THIS PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. IT IS RECOMMENDED THAT CUSTOMERS USE THE FOLLOWING DEVICES FOR HIGH PRESSURE INJECTION, SKU LIST: 383058,383072,383065,383079,383261,383262,383263,383264,383096,383097,383098,383099. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTOS SHOW THAT SLEEVE STOPPER OF THE PRN IS FALLEN OFF. DUE TO NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, THE COMPLAINED SAMPLE IS NOT RECEIVED FOR RELEVANT TESTS , THE ROOT CAUSE OF THIS DEFECT CANNOT BE CONFIRMED AND MAY BE RELATED TO THE PRODUCT IS NOT SUITABLE FOR HIGH PRESSURE INJECTION. H3 OTHER TEXT : SEE NARRATIVE.

    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 INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II ADAPTER DEFECTIVE WAS DAMAGED DURING THE PROCESS OF ADMINISTERING ENHANCED CT CONTRAST AGENT TO THE PATIENT ON (B)(6) 2023, THE RUBBER STOPPER AT THE HEPARIN CAP OF THE INDWELLING NEEDLE FELL OFF HALFWAY, CAUSING THE LIQUID TO SPRAY OUT. A NEW INDWELLING NEEDLE WAS REPLACED AND THE PATIENT WAS INJECTED WITH CONTRAST AGENT AGAIN, WHICH BROUGHT ECONOMIC BENEFITS TO THE PATIENT. LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950712 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2216532 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown