BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 22542460 · Received July 18, 2025

    Report

    Report Number
    3006948883-2025-00306
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 3, 2025
    Report Date
    August 8, 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#4145141): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL, 2024, AND PACKAGED AT R240 & CFS PACKAGE LINE IN JUL, 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 4012467 AND 4081868, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT, AND BASED ON LIMITED INFORMATION, IT IS DIFFICULT TO DETERMINE THE DEFECT STATUS OF THE NEEDLE CORE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED FUNCTIONAL TESTS: RIGIDITY AND TOUGHNESS TESTS OF THE CANNULA. THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. 4. 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. AS THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE CONFIRMED, AND THE SKIN AND VASCULAR CONDITIONS OF THE PATIENT AND THE PUNCTURE METHOD OF THE NURSE ARE UNKNOWN, THE ROOT CAUSE OF THE DEFECT IN THE NEEDLE CORE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP ON THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    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 24GAX0.75IN PRN SLM NEEDLE BROKE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 FOR PNEUMONIA, AND WAS TREATED WITH FLUIDS AS PRESCRIBED, AND WHILE PERFORMING AN INTRAVENOUS INDWELLING NEEDLE PUNCTURE, THE CORE OF THE INDWELLING NEEDLE BROKE, WHICH WAS EXPLAINED TO THE PATIENT, WHO EXPRESSED UNDERSTANDING. THE INDWELLING NEEDLE WAS WITHDRAWN AND THE INDWELLING NEEDLE PUNCTURE WAS REPERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277508 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4145141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown