BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23065424 · Received September 16, 2025

    Report

    Report Number
    3006948883-2025-00690
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 6, 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 CANNULA BATCH USED IN THIS BATCH OF PRODUCTS ARE 5052325 AND 5052322, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 1 PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS: 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. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PRODUCTION PROCESS.THE PHOTOS SHOW A DEFECT OF THE SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING,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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC-383069-ADAPTER /CONNECTOR DEFECTIVE/DAMAGED ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT KNEE MENISCUS REPAIR AND RECONSTRUCTION UNDER GENERAL ANESTHESIA. AN IV CATHETER WAS PLACED FOR INFUSION THAT SAME DAY. DURING A WARD ROUND, THE NURSE DISCOVERED THE HEPARIN CAP ON THE CATHETER HAD FRACTURED, CAUSING BLOOD LEAKAGE. THE INFUSION LINE WAS PROMPTLY CLOSED, THE CATHETER REPLACED, AND INFUSION RESUMED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650565 INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5048556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown