BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA

    MDR report key: 22576944 · Received July 23, 2025

    Report

    Report Number
    3006948883-2025-00327
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 19, 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. THE CUSTOMER RETURNED 1 PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE DEFECT OF THE EXTENDED TUBE LEAKING COULD NOT BE IDENTIFIED IN THE PHOTO. 2. DHR/BHR REVIEW (LOT#4016701): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN FEB 2024, AND PACKAGED AT CFS PACKAGE LINE IN FEB 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 EXTENSION TUBING BATCHES USED IN THIS BATCH OF PRODUCTS IS 4022981, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. 45PSI LEAKAGE TEST THE RETAINED SAMPLE OF THIS BATCH, THE TEST IS QUALIFIED, NO LEAKAGE AT THE SAMPLE. 4. 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; NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE SPECIFIC SITE AND ABNORMAL STATES OF THE LEAKAGE AT THE EXTENSION TUBING FAILED TO IDENTIFY FROM THE RETURNED PHOTO, SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED, THE RELEVANT TESTS CANNOT BE CARRIED OUT, AND THE USE OF THE SAMPLE IS UNKNOWN, SO THE ROOT CAUSE OF THE COMPLAINED DEFECTS CANNOT BE DETERMINED.THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H3: 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 LEAKED WITH POWER INJECTOR. THE HOSPITAL REPORTED THAT THE EXTENSION TUBE LEAKED DURING THE INJECTION OF THE DRUG. THE QUANTITY IS 1 TUBE. THE SAMPLE CANNOT BE RETURNED. PHOTOS CAN BE PROVIDED. A COMPLAINT REPLY LETTER AND A RECEIPT LETTER ARE REQUIRED. GREEN CLAIMS ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785552 BD INTIMA INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4016701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown