BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC

    MDR report key: 18294632 · Received December 8, 2023

    Report

    Report Number
    3014704491-2023-00806
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 14, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830626
    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. DHR/BHR REVIEW(LOT#3199726): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2023, AND PACKAGED AT CFS PACKAGE LINE IN AUGUST 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 PINCH CLAMP BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3202083, 3202084, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE CLAMPING STATE OF PINCH CLAMP CANNOT BE CONFIRMED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR PINCH CLAMP SEALING TEST AND PINCH CLAMP CLAMPING FORCE TEST, AND THE TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. (PLEASE SEE ATTACHMENT (B)(4) FOR THE TEST REPORTS.) 4. IT WAS FOUND IN PREVIOUS TESTS THAT WHEN THE EXTENSION TUBING WAS NOT CENTERED IN THE PINCH CLAMP, THE PINCH CLAMP COULD NOT BE FULLY ACTED. (PLEASE SEE ATTACHMENT (B)(4) FOR THE CLAMPING POSITION VIEW.) 5. 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. AS NO DEFECTIVE SAMPLE RETURNED, AND THE USAGE OF THE INDWELLING NEEDLE IS UNKNOWN, THE ROOT CAUSE OF THE COMPLAINT DEFECTS CANNOT BE DETERMINED. 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 Y 20GAX1.16IN PRN EC SLM NPVC IS DIFFICULT TO CLAMP THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; AFTER INJECTING A NEEDLE INTO A PATIENT, THE BAYONET OF THE NEEDLE TUBE IS NOT STUCK TIGHTLY, CAUSING BLOOD TO RETURN AND BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769339 BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3199726 00382903830626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown