BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 26GA X 0.56IN PRN SLM NPVC

    MDR report key: 23210076 · Received October 3, 2025

    Report

    Report Number
    3006948883-2025-00736
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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. THE CUSTOMER RETURNED 2 PHOTOS AND 1 DEFECTIVE SAMPLE: 1)THE PHOTO SHOWS THAT THE UNIT PACKAGE HAS BEEN OPENED, WITH SKU 383092 AND BATCH NUMBER 3353675. THE BOTTOM FILM OF THE UNIT PACKAGE IS SEVERELY DEFORMED. 2)THE 1 RETURNED SAMPLE SHOWS THAT THE UNIT PACKAGE HAS BEEN OPENED AND MATCHES THE RETURNED PHOTO, THE BOTTOM MEMBRANE OF THE SAMPLE IS VISIBLY DEFORMED. THE NEEDLE IS BENT WITH A CURVATURE OF LESS THAN 10°. 2. DHR/BHR REVIEW(LOT#3353675): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT MANUAL LINE IN JAN 2024,AND PACKAGED AT CFS PACKAGE LINE IN JAN 2024. 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 CANNULA BATCH USED IN THIS BATCH OF PRODUCT IS 1140646, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BENT NEEDLE FOUND. TAKE THE RETAINED SAMPLE FOR CANNULA RIGIDITY AND TOUGHNESS TEST, AND THE TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 4. CAUSE ANALYSIS: 1)THE SAMPLE GAUGE IS 26G, THE NEEDLE IS THIN AND EASY TO BEND. 2)DURING THE PRODUCT MANUFACTURING PROCESS, ABNORMAL COLLISIONS MAY OCCUR. IN THE UNIT PACKAGING STAGE, DUE TO MANUAL PLACEMENT AND THE SPATIAL LIMITATIONS OF THE PACKAGING CAVITY, IMPROPER PLACEMENT MAY LEAD TO BENT NEEDLES. THEREFORE, THE PLANT HAS IMPLEMENTED MULTIPLE INSPECTION PROCEDURES DURING PRODUCTION, INCLUDING PUNCTURE TESTING, NEEDLE DISTANCE MEASUREMENT, FINISHED PRODUCT ASSEMBLY INSPECTION, AND PACKAGING APPEARANCE INSPECTION, TO ENSURE PRODUCT QUALITY. 3)EXTERNAL FORCES SUCH AS VIBRATION OR COMPRESSION DURING TRANSPORTATION OR STORAGE MAY ALSO CAUSE NEEDLE TUBE BENDING. 4)BASED ON THE DEFORMATION OF THE BOTTOM FILM OF THE RETURNED SAMPLE, IT CAN BE CONCLUDED THAT THE SAMPLE WAS SUBJECTED TO EXTERNAL FORCES SUCH AS COMPRESSION OR IMPACT. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. BASED ON THE DEFECT CONDITION SHOWN IN THE RETURNED PHOTOS AND SAMPLE, IT IS INFERRED THAT THE ROOT CAUSE OF THE NEEDLE TUBE BENDING IS EXTERNAL FORCE, SUCH AS COMPRESSION, EXPERIENCED DURING TRANSPORTATION OR STORAGE. THIS ISSUE IS RELATED TO LOGISTICS OR WAREHOUSING. THE PLANT WILL CONTINUE TO MONITOR AND FOLLOW UP ON SUCH DEFECTS.

    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 AVAILABLE.

    Description of Event or Problem · 0

    GIVE THE CHILD AN INTRAVENOUS INJECTION, MATERIAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457671 INTIMA-II 26GA X 0.56IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3353675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown