BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 21961359 · Received May 5, 2025

    Report

    Report Number
    3006948883-2025-00123
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    January 18, 2025
    Report Date
    May 27, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903832842
    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#: 4233027): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN OCT 2024 AND PACKAGED AT R245 PACKAGE LINE IN OCT 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. 2. NO DEFECTIVE SAMPLE AND PHOTOGRAPH HAVE BEEN RECEIVED, AND BASED ON THE LIMITED INFORMATION, IT IS DIFFICULT TO DETERMINE THE SPECIFIC BROKEN AND LEAKAGE SITE OF THE INDWELLING NEEDLE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR LEAKAGE TEST, THE LEAKAGE TEST IS QUALIFIED, AND THE TEST IN ACCORDANCE WITH PRODUCT SPECIFICATIONS, NO LEAKAGE WAS FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER EXAMINATION, THE DAMAGE STATE OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II CATHETER DAMAGED AND LEAKED ON (B)(6) 2025, A PATIENT WAS ADMITTED TO THE HOSPITAL WITH A NEW CEREBRAL INFARCTION AND REQUIRED INTRAVENOUS INFUSION. WHILE ADMINISTERING THE INFUSION, THE MEDICAL STAFF OPENED THE CANNULA AND FOUND THAT IT WAS BROKEN, CAUSING FLUID TO LEAK OUT AND RENDERING IT UNUSABLE. IT WAS IMMEDIATELY REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458423 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233027 00382903832842

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown