BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN

    MDR report key: 18068454 · Received November 3, 2023

    Report

    Report Number
    3014704491-2023-00691
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 7, 2023
    Report Date
    December 17, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    K200891
    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. NO ACTUAL SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. BASED ON THE DESCRIPTION OF THE INFORMATION AVAILABLE, WE UNDERSTAND THAT THE FAILURE MODE OF THE PRODUCT IS: NEEDLE THROUGH CATHETER. 2. DHR/BHR REVIEW(LOT#3080061): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN (B)(6) 2023, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 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. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO NEEDLE THROUGH CATHETER IS FOUND. PLEASE SEE ATTACHMENT (B)(4) FOR THE CHECK REPORT. 4. AFTER THE FINAL ASSEMBLY OF THE CATHETER HUB AND PADDLE HUB IN ZONE 5, THERE ARE VISUAL DETECTION SYSTEMS TO DETECT 100% OF NEEDLE THROUGH CATHETER AND LIE DISTANCE (PLEASE SEE ATTACHMENT (B)(4) FOR PROCESS OF ZONE 5). THE VISION DETECTION SYSTEMS ARE CHALLENGED WITH STANDARD SAMPLES EVERY DAY AT 7:00, 19:00 AND WHEN CHANGING PRODUCT GAUGES TO ENSURE THE EFFECTIVENESS OF THE DETECTION. 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, NO DEFECTIVE SAMPLE IS RECEIVED, AND THE USAGE OF THE INDWELLING NEEDLE IS UNKNOWN, THE ROOT CAUSE OF THE COMPLAINT DEFECT 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 THAT BD 9071846 - INTIMA-II Y 24GAX0.75IN NEEDLE PULLED OUT OF HUB THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THE STEEL NEEDLE OF THE INDWELLING NEEDLE IS EXPOSED OUTSIDE THE HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852422 BD INTIMA-II Y 24GAX0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080061 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown