BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21842291 · Received April 15, 2025

    Report

    Report Number
    3006948883-2025-00071
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    February 23, 2025
    Report Date
    May 6, 2025
    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#4296353): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN NOV 2024, AND PACKAGED AT R240 PACKAGE LINE IN NOV 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 BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4211852 AND 4211851, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 3 SAMPLES, SKU WAS 383083, THE BATCH NUMBER WAS 4296353, OF WHICH 2-UNIT PACKAGES WERE NOT OPENED, 1 UNIT PACKAGE WAS OPENED, AND ALL 3 SAMPLES SHOWED THAT THE SURFACE OF THE NEEDLE WAS SMOOTH WITHOUT BIFURCATION OR DAMAGE. 3. THE RETURNED SAMPLES WERE PERFORMED RELEVANT FUNCTIONAL TESTS: LIE DISTANCE TEST, PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST. THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 4. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE TEST, PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST. THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 5. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT CUSTOMERS SHOULD PAY ATTENTION TO THE CONTROL OF THE INITIAL PUNCTURE ANGLE (15-30 DEGREES IN PRINCIPLE) DURING THE PUNCTURE PROCESS, WHICH IS CONDUCIVE TO FEEDING THE NEEDLE AND CATHETER INTO THE VEIN. IF THE INITIAL PUNCTURE ANGLE IS TOO LOW, THE SKIN RESISTANCE TO THE NEEDLE AND CATHETER ENTERING THE VEIN INCREASE. 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 REGARDING THIS BATCH OF PRODUCTS. THE RETURNED SAMPLE IS FREE OF DEFECTS IN APPEARANCE AND THE TEST RESULTS ARE IN ACCORDANCE WITH THE PRODUCT SPECIFICATIONS AND THE USE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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 Y 24GAX0.75IN PRN EC SLM NPVC CATHETER WAS DAMAGED/DEFECTIVE. ON (B)(6) 2025 WHEN A HEALTHCARE WORKER WAS PERFORMING AN INDWELLING IV PUNCTURE FOR A PATIENT USING A CLOSED IV INDWELLING NEEDLE, THE NEEDLE BECAME STUCK AND BIFURCATED, RESULTING IN AN UNFAVORABLE PUNCTURE, THE OPERATION WAS STOPPED IMMEDIATELY, THE PATIENT WAS GIVEN A DISINFECTED AND COMFORTED NEEDLE EYE, AND AFTER REPLACING THE NEEDLE WITH A DIFFERENT BRAND OF INDWELLING NEEDLE, THE PATIENT WAS GIVEN AN INDWELLING IV PUNCTURE THAT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108281 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4296353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown