BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/PRN SLM NPVC

    MDR report key: 21119084 · Received January 9, 2025

    Report

    Report Number
    3002601200-2024-00807
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 18, 2024
    Report Date
    February 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830664
    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

    DHR/BHR REVIEW LOT#4198424. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JULY, 2024, AND PACKAGED AT R245 PACKAGE LINE IN AUG, 2024. BATCH SIZE IS (B)(4) EA. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. THE PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 4173772, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 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 (B)(4). PLANT RECEIVED 4PCS SAMPLES FROM CUSTOMER, ALL THE 4PCS SAMPLE WERE NOT OPENED, AND THE LATEX PLUG OF THE PRN HAS WHITENED ISSUE AND BROKEN IN DIFFERENT DEGREES. CHECK THE RETAINED SAMPLES OF THE COMPLAINT BATCH IN PLANT, THE SLEEVE STOPPERS AT THE TOP OF PRNS ARE BROKEN AND WHITENED. WHITENED ISSUE AND BROKEN ISSUE 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. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/PRN SLM NPVC HAD MOLD BEFORE UNPACKING, I FOUND THAT THE HEPARIN CAP OF THE INTRAVENOUS CATHETER WAS MOLDY. I NEED TO FILE A CLAIM AND A COMPLAINT RESPONSE LETTER, BUT NOT A COMPLAINT ACCEPTANCE LETTER. DEFECTIVE PRODUCTS CAN BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169748 BD INTIMA-II Y 22GAX1.00IN PRN/PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4198424 00382903830664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown