BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN

    MDR report key: 18068843 · Received November 3, 2023

    Report

    Report Number
    3014704491-2023-00696
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 12, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    PMA / PMN Number
    NA
    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. DHR/BHR REVIEW(LOT#2199811): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN AUGUST 2022, AND PACKAGED AT CFS PACKAGE LINE IN AUGUST 2022. 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 2120663, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. TAKE THE RETAINED SAMPLES OF THIS BATCH AND CHECK THE NEEDLES UNDER THE MICROSCOPE. NO RUSTS ARE FOUND. PLEASE SEE THE ATTACHED PHOTOS. 4. THE NEEDLE IS MADE OF 304 SS, WHICH HAS GOOD CORROSION RESISTANCE UNDER NORMAL CIRCUMSTANCES, BUT IN SPECIAL CONDITIONS (SUCH AS IN THE AIR CONTAINING CHLORINATED CHEMICALS), THE HEAD OF SOME NEEDLES MAY RUST, AND THE PLANT DOES NOT HAVE THE CONDITIONS TO CAUSE SUCH DEFECT IN THE PRODUCTION PROCESS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND THE STORAGE ENVIRONMENT OF THE COMPLAINED SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE RUSTING AND BLACKENING OF THE BEVEL OF THE NEEDLE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 BD INTIMA-II Y 22GAX1.00IN HAD RUST / CORROSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; AFTER UNPACKING, THE BEVEL OF THE NEEDLE WAS RUSTY AND BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132133 BD INTIMA-II Y 22GAX1.00IN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2199811 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown