BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20992324 · Received December 20, 2024

    Report

    Report Number
    3002601200-2024-00759
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 16, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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

    1. DHR/BHR REVIEW LOT# 4171125. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2024, AND PACKAGED AT R240 PACKAGE LINE IN JULY 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 SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST 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 SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED AND NO FURTHER EXAMINATION CAN BE CONDUCTED, THE ROOT CAUSE OF THE BLEEDING AT THE BOTTOM CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT BD.

    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 LEAKAGE AT CATHETER JUNCTION. LEAKAGE OF BLOOD FROM THE BOTTOM OF THE INDWELLING NEEDLE AFTER SUCCESSFUL PUNCTURE OF THE PATIENT, FOLLOWED BY REPLACEMENT OF THE INDWELLING NEEDLE AND RE-PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328476 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown