BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 23832807 · Received December 17, 2025

    Report

    Report Number
    3006948883-2025-00952
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    October 15, 2025
    Report Date
    February 28, 2026
    Manufacturer
    BD SUZHOU (MDS)
    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#5048530): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAR 2025 AND PACKAGED AT R240 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 CANNULA BATCH USED IN THIS BATCH OF PRODUCTS ARE 5023497, 5017769 AND 4328543. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED ONE PHOTO AND DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE HEPARIN CAP RUBBER STOPPER OF THE SAMPLE IS DAMAGED. 3. SAMPLE FROM THIS BATCH WAS TAKEN FOR VISUAL INSPECTION, AND NO DAMAGE OR OTHER ABNORMALITIES WERE FOUND ON THE HEPARIN CAPS. 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 ON THE SAMPLE, AND THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. 4. POSSIBLE FACTORS CAUSING DAMAGE TO LATEX STOPPERS: 1) RAW MATERIAL FACTORS (AGING OF HEPARIN CAP MATERIALS, POOR ELASTICITY OF THE LATEX STOPPER). 2) EXCESSIVELY HIGH TEMPERATURE OR HUMIDITY IN PRODUCT STORAGE ENVIRONMENTS CAN ACCELERATE THE AGING OR DAMAGE OF THE LATEX STOPPER. 3) IMPROPER NEEDLE ANGLE DURING PUNCTURE; IF THE NEEDLE DOES NOT ENTER THE CENTER OF THE LATEX STOPPER AND PUNCTURES IT AT AN ANGLE, IT CAN CAUSE DAMAGE TO THE LATEX STOPPER. 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 NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS.THE RETURNED PHOTO SHOWS DAMAGE TO THE LATEX STOPPER OF THE PRN,BUT AS NO OBVIOUS PRN ASSEMBLY ISSUE CAN BE IDENTIFIED FROM THE PHOTOS,AND 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.

    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

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC ADAPTER / CONNECTOR DEFECTIVE / DAMAGED. DURING INTRAVENOUS INFUSION FOR PATIENT 52, THE HEPARIN CAP ON THE INDWELLING NEEDLE WAS FOUND TO BE FRACTURED WHILE DISINFECTING IT. THE CAP WAS PROMPTLY REPLACED WITH A NEW CLOSED-SYSTEM INDWELLING VENOUS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181687 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 5048530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown