BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19273534 · Received May 8, 2024

    Report

    Report Number
    3002601200-2024-00167
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 14, 2024
    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, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS A WITHDRAWN NEEDLE, THE COLOR OF THE NOTCH OF THE NEEDLE IS SLIGHTLY DARK, AND THE TIP OF THE NEEDLE IS NOT RUSTY. 2. DHR/BHR REVIEW(LOT#3325153): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN NOVEMBER 2023, AND PACKAGED AT CFS PACKAGE LINE IN NOVEMBER 2023. 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 BATCH USED IN THIS BATCH OF PRODUCTS IS 3142078, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 5) REVIEW THE BATCH RECORDS, NO MATERIAL, PROCESS CHANGE. THE STERILIZATION PROCESS IS NORMAL, THE BI STERILITY TEST IS PASSED, AND THE EO RESIDUE TEST IS PASSED, THE PRODUCTS MEET THE REQUIREMENT OF BI STERILITY TEST BEFORE RELEASE, PLEASE SEE ATTACHMENT (B)(4) COC FOR THE QUALITY CERTIFICATE. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN, AND THE TIPS OF THE NEEDLES ARE EXAMINED UNDER THE MICROSCOPE. NO RUST IS FOUND. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTOS. 4. CAUSE ANALYSIS: 1) THE NEEDLE IS MADE OF 304 STAINLESS STEEL AND LUBRICATED BY SILICONE, WHICH HAS GOOD RUST RESISTANCE UNDER NORMAL CIRCUMSTANCES, BUT UNDER SPECIAL CONDITIONS (SUCH AS IN THE AIR CONTAINING CHLORINATED CHEMICALS), THE HEAD OF THE NEEDLE MAY RUST. THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE THE DEFECT IN THE PRODUCTION PROCESS. 2) THE NOTCH OF THE NEEDLE IS WRAPPED IN THE CATHETER, AND RUST HAS NEVER OCCURRED. THE SLIGHTLY DARK COLOR OF THE NOTCH IS RELATED TO THE PRODUCTION PROCESS OF THE NEEDLE AND THE USE OF THE PRODUCT. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE ROOT CAUSE CANNOT BE DETERMINED AS THE RUSTY NEEDLE TIP IS NOT IDENTIFIED IN THE RETURNED PHOTO AND NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TESTING AND ANALYSIS.

    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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC HAD RUST WHEN THE OBSTETRICS TEACHER PULLED OUT THE PATIENT AFTER PUNCTURE, HE FOUND THAT THE TIP OF THE NEEDLE WAS RUSTY; SAMPLES CANNOT BE RETURNED, PHOTOS ARE PROVIDED; GREEN CLAIMS ARE REQUIRED, A COMPLAINT RESPONSE LETTER IS REQUIRED, AND A COMPLAINT ACCEPTANCE LETTER IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101229 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3325153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown