BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 18623675 · Received February 1, 2024

    Report

    Report Number
    3002601200-2024-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 12, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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#: 3250463): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEPTEMBER 2023, AND PACKAGED AT R240 PACKAGE LINE IN SEPTEMBER 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND THE DEFECT STATUS OF BOTH THE PRN AND THE NEEDLE BODY BEING TORN CANNOT BE CONFIRMED. 3. THE RETAINED SAMPLES OF THIS BATCH ARE CHECKED, AND NO COMPLAINED DEFECTS 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 ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECT OF THE COMPLAINED SAMPLE CANNOT BE CONFIRMED, THE ROOT CAUSE OF CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP ON THE COMPLAINT.

    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 INTIMA-II 24GAX0.75IN PRN SLM NPVC WAS FOUND DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSE INSERTS AN INDWELLING NEEDLE INTO THE VENIPUNCTURE HOLE OF PATIENT (B)(6) . WHEN SHE OPENED THE INDWELLING NEEDLE FOR INSPECTION, SHE FOUND THAT THE HEPARIN CAP AND NEEDLE BODY OF THE INDWELLING NEEDLE WERE TORN., REPLACE THE INDWELLING NEEDLE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419965 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3250463 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown