BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22329766 · Received June 25, 2025

    Report

    Report Number
    3006948883-2025-00224
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 27, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. THE CUSTOMER HAS RETURNED ONE DEFECTIVE SAMPLE: 1) INSPECT THE APPEARANCE OF THE RETURNED SAMPLE, NO BLACK DOTS ON THE NEEDLE TIPS AND NO BENT NEEDLES WERE FOUND IN THE COMPLAINTS. 2) THE SAMPLE IS PERFORMED ON CANNULA RIGIDITY AND TOUGHNESS TEST, AND THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 2. DHR/BHR REVIEW(LOT#4313476): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN DEC 2024, AND PACKAGED AT R240 PACKAGE LINE IN DEC 2024. 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 CANNULA BATCH USED IN THIS BATCH OF PRODUCTS IS 4211851, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BENT NEEDLE AND FOREIGN MATTER FOUND. TAKE THE RETAINED SAMPLE FOR CANNULA RIGIDITY AND TOUGHNESS TEST, AND THE TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 4. ABOUT NEEDLE BENT: 1)ABNORMAL COLLISION OF EQUIPMENT IN THE PROCESS OF PRODUCT MANUFACTURING AND IN THE UNIT PACKAGING PROCESS, IMPROPER PLACEMENT MAY RESULT IN BENT NEEDLES. THEREFORE, THE PLANT CONDUCTS MULTIPLE INSPECTIONS DURING THE PRODUCTION PROCESS, INCLUDING NEEDLE PUNCTURE CHECKS, DISTANCE DETECTION, FINISHED PRODUCT ASSEMBLY INSPECTIONS, AND PACKAGING APPEARANCE INSPECTIONS TO ENSURE PRODUCT QUALITY. 2) IN ADDITION, EXTERNAL FORCES SUCH AS VIBRATIONS AND SQUEEZING DURING TRANSPORTATION OR STORAGE MAY ALSO CAUSE THE NEEDLE TO BEND. 5. ABOUT THE BLACK DOTS ON THE NEEDLE TIP:THE NEEDLE OF THE INDWELLING NEEDLE IS DUE TO THE MANUFACTURING PROCESS,UNDER DIFFERENT LIGHTING CONDITIONS, IT SOMETIMES MAY APPEAR THAT THERE ARE BLACK FOREIGN OBJECTS ATTACHED TO THE TIP OF THE NEEDLE. SINCE NO BLACK DOTS WERE FOUND ON THE NEEDLE TIP OF THE RETURNED SAMPLE, IT IS BELIEVED THAT IT MAY BE THE SHADOW OF THE NEEDLE TIP UNDER THE LIGHT. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THROUGH INSPECTION AND ANALYSIS OF THE RETURNED SAMPLE, IT IS DETERMINED THAT THE BLACK DOT AT THE TIP OF THE NEEDLE IS LIKELY THE SHADOW OF THE NEEDLE TIP UNDER THE LIGHT. SINCE NO BENDING OF THE NEEDLE TUBE WAS FOUND IN THE RETURNED SAMPLES, SO THE ROOT CAUSE OF THE BENDING OF THE NEEDLE CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAD FOREIGN MATTER WHEN YOU OPEN THE PACKAGE, YOU FIND A BENT NEEDLE TIP AND A BLACK SPOT AT THE TIP OF THE NEEDLE, YOU CAN RETURN THE DEFECTIVE PRODUCT, YOU NEED TO MAKE A CLAIM, YOU NEED A COMPLAINT REPLY LETTER, YOU NEED A COMPLAINT RECEIPT LETTER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069801 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4313476 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown