BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19991783 · Received August 15, 2024

    Report

    Report Number
    3002601200-2024-00385
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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 RETURNED 1 PHOTO, NO DEFECTIVE SAMPLE. THE NEEDLE HEAD STATES ARE NOT RECOGNIZED IN THIS PHOTO. 2. DHR/BHR REVIEW LOT-4052017: 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS. PLEASE SEE ATTACHMENT FOR TEST REPORTS. 1-LIE DISTANCE IS MEASURED, AND THE RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 2-PENETRATION FORCE TEST IS PERFORMED, THE NEEDLE TIP FORCE, CATHETER TIP FORCE AND CATHETER DRAG FORCE ALL MEET THE PRODUCT SPECIFICATIONS. 4. THE BLUNTNESS OF THE NEEDLE MAY BE RELATED TO THE QUALITY OF THE PRODUCT, AND MAY ALSO BE RELATED TO THE PATIENT'S SKIN, VEIN CONDITIONS AND PUNCTURE METHOD. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE AND CATHETER. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR FURTHER TESTING, THE ROOT CAUSE OF THE BLUNTNESS OF THE NEEDLE CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED. USED AS PRESCRIBED, FOUND THE INDWELLING NEEDLE A BIT BLUNT AFTER USE, AFTER WITHDRAWING THE STEEL NEEDLE, BLOOD CAME OUT FROM THE TAILPIECE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176777 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4052017 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown