BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21013157 · Received December 24, 2024

    Report

    Report Number
    3002601200-2024-00771
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    September 3, 2024
    Report Date
    January 9, 2025
    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

    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#4081489. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4). 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 NO DEFECTIVE SAMPLE IS RETURNED AND NO FURTHER EXAMINATION CAN BE CARRIED OUT, THE ROOT CAUSE OF THE LEAKAGE AT THE NEEDLE HUB CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED AT CATHETER JUNCTION. BEFORE PLACING THE INDWELLING NEEDLE IN THE PATIENT, THE NURSE NOTICES WATER LEAKING FROM THE SEAT OF THE INDWELLING NEEDLE DURING VENTING, CONSIDERS THE INDWELLING NEEDLE TO BE LEAKING, AND REPLACES IT WITH A NEW ONE TO PERFORM THE PUNCTURE FOR THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966246 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown