BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21139351 · Received January 13, 2025

    Report

    Report Number
    3002601200-2024-00816
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 20, 2024
    Report Date
    February 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830800
    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#3080107 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL, 2023, AND PACKAGED AT R245 PACKAGE LINE IN APRIL, 2023. BATCH SIZE IS 19000 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 PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 308307 & 3083081, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 5) CHECKED ALL COMPLAINT LOT OF THE BATCH RECORD, RAW MATERIAL PROCESSES NO CHANGES. THE STERILIZATION PROCESS IS NORMAL, THE BI STERILITY TEST PASSED, AND THE EO RESIDUE TEST PASSED, THE PRODUCT MET THE REQUIREMENT OF BI STERILITY TEST BEFORE RELEASED, SEE THE ATTACHMENT 383080-3080107 COC 2.THE CUSTOMER RETURNED 4 SAMPLES. THE SAMPLE GAUGE IS 24G, P/N IS 383080, BATCH NUMBER IS 3080107. ALL THE 4PCS SAMPLES HAVE NOT BEEN OPENED. THE SLEEVE STOPPERS AT THE TOP OF PRNS ARE BROKEN AND WHITENED (NON-FOREIGN MATTER). SEE ATTACHMENT PR# (B)(4) FOR THE PHOTO. 3.CHECK THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND, PLEASE SEE THE ATTACHED PR# (B)(4). 4. WHITENED ISSUE AND DAMAGE OF LATEX PLUG OF PRN IS A KIND OF AGING PHENOMENON.OBSERVE THE RETAINED PRODUCTS AND STORE THEM UNDER CONSTANT TEMPERATURE AND HUMIDITY, NO AGING PHENOMENON HAS BEEN FOUND IN 3 YEARS.ACCORDING TO PREVIOUS EXPERIENCE, HIGH TEMPERATURE, HIGH LIGHT INTENSITY, STRONG OXIDATION OR HUMID ENVIRONMENT CAN CAUSE PRODUCT OXIDATION FAILURE. THE ENVIRONMENT IS RELATIVELY STABLE IN THE PRODUCTION PROCESS, WHICH WILL NOT CAUSE THE AGING PHENOMENON. THE DEFECT MAY BE RELATED TO TRANSPORT AND STORAGE CONDITIONS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. CONCLUSION NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. HIGH TEMPERATURE, HIGH LIGHT INTENSITY, STRONG OXIDATION OR HUMID ENVIRONMENT CAN CAUSE PRODUCT OXIDATION FAILURE. THE ENVIRONMENT IS RELATIVELY STABLE IN THE PRODUCTION PROCESS, WHICH WILL NOT CAUSE THE AGING PHENOMENON, SO THE DEFECT MAY BE RELATED TO TRANSPORT AND STORAGE CONDITIONS. PLANT WILL CONTINUE TRACKING THIS KIND OF COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC HAD MOLD. BEFORE UNPACKING, I FOUND THAT THE HEPARIN CAP WAS MOLDY. I NEED TO FILE A CLAIM, A COMPLAINT RESPONSE LETTER, AND A COMPLAINT ACCEPTANCE LETTER. I CAN RETURN 10 DEFECTIVE PRODUCTS, AND I HAVE PHOTOS TO PROVIDE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452281 BD INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080107 00382903830800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown