BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC

    MDR report key: 23594696 · Received November 19, 2025

    Report

    Report Number
    3006948883-2025-00887
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 10, 2025
    Report Date
    February 1, 2026
    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. DHR/BHR REVIEW (LOT#5202698): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUG 2025 AND PACKAGED AT R245 PACKAGE LINE IN AUG 2025. 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 NEEDLE TUBE BATCH NO. 4362858 USED FOR THIS LOT WAS INSPECTED UPON RECEIPT, AND ALL RESULTS MET THE INCOMING INSPECTION STANDARDS. 5)THE CATHETER BATCH USED FOR THIS PRODUCT LOT IS 5146801. A REVIEW OF THE INCOMING INSPECTION RECORDS SHOWS NO ABNORMALITIES. 2. THE CUSTOMER RETURNED ONE PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE UNIT PACKAGE HAS BEEN OPENED AND THE NEEDLE HAS PIERCED THE CATHETER. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE, PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST. THE TEST RESULTS SHOW THAT THEY ALL MEET THE PRODUCT SPECIFICATIONS. 4. AFTER THE FINAL ASSEMBLY OF THE CATHETER HUB AND PADDLE HUB IN ZONE 5, THERE ARE VISUAL DETECTION SYSTEMS TO DETECT 100% NEEDLE THROUGH CATHETER. THE VISION DETECTION SYSTEMS ARE CHALLENGED WITH STANDARD SAMPLES EVERY 12 HOURS AND WHEN CHANGING GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 5. IRREGULAR HANDLING DURING THE PUNCTURE PROCESS-SUCH AS LOOSENING THE NEEDLE CORE IMPROPERLY, REPEATED PUNCTURING, OR WITHDRAWING THE NEEDLE CORE TOO EARLY-CAN LEAD TO THE NEEDLE CORE PUNCTURING THE CATHETER. BASED ON PAST MARKET VISIT EXPERIENCE, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED: INSERT THE NEEDLE WITH THE BEVEL FACING UPWARD AT AN ANGLE OF 15° TO 30°, THEN LOWER THE ANGLE TO 5° TO 10° TO CONTINUE ADVANCING THE NEEDLE AND CATHETER. AVOID PREMATURE NEEDLE WITHDRAWAL AND REPEATED PUNCTURING. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS THAT THE NEEDLE CORE PUNCTURED THE CATHETER, BUT AS NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER EXAMINATION, SO THE ROOT CAUSE OF NEEDLE THROUGH CATHETER CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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

    ON (B)(6) 2025, FEEDBACK WAS RECEIVED FROM NURSES IN THE USING DEPARTMENT: DURING THE PLACEMENT OF AN INDWELLING NEEDLE ON (B)(6) 2025, NO BLOOD RETURN WAS OBSERVED. MANUAL PALPATION INDICATED NEEDLE DISPLACEMENT WITHIN THE CATHETER, CAUSING PATIENT DISCOMFORT. UPON REMOVAL, THE NEEDLE WAS FOUND DETACHED FROM THE INDWELLING CATHETER. A NEW PUNCTURE WAS PERFORMED. MULTIPLE SIMILAR INCIDENTS HAVE RECENTLY OCCURRED WITH THIS BATCH OF PRODUCTS. ALTHOUGH THE NEEDLE WAS INITIALLY INSIDE THE CATHETER DURING INSERTION, IT IS POSSIBLE THAT THE CONNECTION BETWEEN THE NEEDLE AND THE CATHETER BODY WAS NOT SECURE, CAUSING THE NEEDLE TO SEPARATE FROM THE CATHETER DURING THE INSERTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234949 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5202698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown