BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20032749 · Received August 22, 2024

    Report

    Report Number
    3002601200-2024-00392
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 18, 2024
    Report Date
    September 9, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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. THE CUSTOMER RETURNED 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW LEAKAGE AT THE SEPTUM. 2. DHR/BHR REVIEW LOT#4052015 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. DUE TO SIMILAR COMPLAINTS RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, THE PLANT HAS CONDUCTED 800MM SIMULATED CLINICAL LEAKAGE TEST ON THE RETAINED SAMPLES OF THIS BATCH AND FOUND THAT A FEW SAMPLES LEAKED AT THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. 4. IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. THE RETURNED PHOTOS SHOW LEAKAGE AT THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H.3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 LEAKED. WHEN USED, BLOOD WILL FLOW OUT OF THE ISOLATION PLUG. ONE SAMPLE CAN BE RETURNED, WITH PHOTOS. GREEN CLAIMS ARE REQUIRED, COMPLAINT REPLY LETTER IS REQUIRED, AND COMPLAINT RECEIPT LETTER IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26597 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown