BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    MDR report key: 23065938 · Received September 16, 2025

    Report

    Report Number
    3006948883-2025-00691
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 24, 2025
    Report Date
    October 21, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW (LOT#5048556): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MAR 2025 AND PACKAGED AT R240 & CFS PACKAGE LINE IN MAR 2025. WORK ORDER QUANTITY WAS (B)(4) PCS. 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 5052325 AND 5052322. REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 2 PHOTOS BUT DID NOT RETURN THE DEFECTIVE SAMPLE. ONE OF THE PHOTOS SHOWS THAT THE PRN OF THE DEFECTIVE SAMPLE HAS A BULGING DEFECT. ANOTHER PHOTO SHOWS THAT THE PRN LATEX STOPPER IS SEPARATED FROM THE BASE, AND THE ASSEMBLY POSITION OF THE BIG END OF THE SLEEVE STOPPER AND THE SHRINKAGE OF THE SHRINK BAND HAVE NO OBVIOUS ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE PULL FORCE TEST OF THE PRN (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING) AND 45PSI LEAKAGE TEST, AND THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. 4. THE POSSIBLE FACTORS AFFECTING THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING: RAW MATERIAL FACTORS (INCLUDING THE TENSION OF THE SLEEVE STOPPER, THE DEGREE OF SHRINKAGE OF THE SHRINK BAND), THE ASSEMBLY OF THE PRN, THE FLOW RATE AND PRESSURE DURING THE USE OF THE INDWELLING NEEDLE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PRODUCTION PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOW DEFECTS OF PRN BULGING AND SEPARATION OF THE RUBBER STOPPER FROM THE BASE, BUT AS NO OBVIOUS PRN ASSEMBLY ISSUE CAN BE IDENTIFIED FROM THE PHOTOGRAPHS PROVIDED, AND THAT THE DEFECTIVE SAMPLE WAS NOT RETURNED, THE RELEVANT TESTS COULD NOT BE CONDUCTED, SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC - LEAKAGE. BED (B)(4): ADMITTED FOR TREATMENT OF A DISTAL LEFT RADIUS FRACTURE. ON (B)(6) 2025 AT 09:00, A 22G CLOSED-SYSTEM IV CATHETER WAS INSERTED FOR INTRAVENOUS INFUSION. APPROXIMATELY 20 MINUTES AFTER SUCCESSFUL VENOUS ACCESS AND INITIATION OF INFUSION, THE ORIGINAL HEPARIN CAP ON THE CATHETER WAS OBSERVED TO BE BULGING WITH LEAKAGE OF INFUSION FLUID. THE PROBLEMATIC CATHETER WAS IMMEDIATELY REMOVED, AND A NEW VENOUS PUNCTURE WAS PERFORMED. SUBSEQUENT USE PROCEEDED NORMALLY WITHOUT CAUSING ANY ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681004 NTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5048556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown