BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22964629 · Received September 4, 2025

    Report

    Report Number
    3006948883-2025-00669
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 9, 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#5101611): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APR 2025 AND PACKAGED AT R240 & CFS PACKAGE LINE IN APR 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. 100% OCCLUSION TEST IS PERFORMED DURING PRODUCTION. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4) THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 5080766, 5023495 AND 5080750. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED THREE PHOTOS BUT DID NOT PROVIDE THE DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE BATCH NUMBER IS 5101611, AND THE LATEX STOPPER ON THE PRN OF THE INDWELLING NEEDLE IS MISSING. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND THE PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING), THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. 4. THE SEPARATION OF THE PRN COMPONENTS IS CAUSED BY VARIOUS FACTORS: RAW MATERIAL FACTORS (INCLUDING THE TENSION OF THE SLEEVE STOPPER, THE DEGREE OF SHRINKAGE OF THE SHRINK BAND), THE ASSEMBLY OF PRN DURING THE PRODUCTION PROCESS, THE FLOW RATE AND PRESSURE DURING THE USE OF THE INDWELLING NEEDLE MAY CAUSE THE SEPARATION OF THE PRN COMPONENT. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOW THAT THE LATEX STOPPER ON THE PRN IS MISSING. AS NO OBVIOUS ASSEMBLY ISSUE OF THE PRN CAN BE IDENTIFIED FROM THE PHOTOS, AND SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED FOR FURTHER INSPECTION, SO THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TRACKING THIS KIND OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC, LEAKAGE. THIS PRODUCT HAS EXPERIENCED BLEEDING FROM THE HEPARIN CAP DURING USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799975 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown