BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20485444 · Received October 18, 2024

    Report

    Report Number
    3002601200-2024-00529
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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#4052073. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTERS ARE FOUND. PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): 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. AS THE STATUS AND COMPOSITION OF THE FOREIGN MATTER IN THE INDWELLING NEEDLE CANNOT BE CONFIRMED, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR SUCH DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM FOREIGN MATTER. ON (B)(6) 2024, A PATIENT WAS GIVEN AN INFUSION USING AN INDWELLING NEEDLE AND A FOREIGN OBJECT WAS FOUND IN THE INDWELLING NEEDLE, WHICH WAS LATER REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229271 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052073 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown