BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20800681 · Received November 27, 2024

    Report

    Report Number
    3002601200-2024-00668
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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

    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#4052033. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MARCH 2024, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 2024. WORK ORDER QUANTITY WAS 198,000 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 SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTERS ARE FOUND AT THE FRONT END OF THE NEEDLES. PLEASE SEE ATTACHMENT FOR THE PHOTO. 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. SINCE THE STATUS AND COMPOSITION OF THE FOREIGN MATTER AT THE FRONT END OF THE INDWELLING NEEDLE CANNOT BE CONFIRMED, THE SOURCE OF THE FOREIGN MATTER CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM FOREIGN MATTER ON (B)(6) 2024, WHILE GIVING A PATIENT AN INDWELLING PUNCTURE IN A VEIN, A FOREIGN OBJECT WAS FOUND ADHERING TO THE FRONT OF THE INDWELLING NEEDLE, WHICH WAS IMMEDIATELY REPLACED WITH A NEW ONE WITHOUT HARM TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832392 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052033 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown