BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20066509 · Received August 26, 2024

    Report

    Report Number
    3002601200-2024-00407
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 13, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO DEFECTIVE SAMPLE AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 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. 4-IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED AN IN-DEPTH INVESTIGATION TO ALL POTENTIAL CAUSES 3. THE 800MM SIMULATED CLINICAL LEAKAGE TEST WAS CONDUCTED ON THE RETAINED SAMPLES FROM THIS BATCH. IT WAS FOUND THAT A FEW SAMPLES LEAKED AT THE END OF THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. CONCLUSION(S): IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED AN IN-DEPTH INVESTIGATION TO ALL POTENTIAL CAUSES TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM AFTER THE INTRAVENOUS INDWELLING NEEDLE WAS PUNCTURED, IT WAS FOUND THAT THE PATIENT'S BLOOD RETURNED AND WAS BLEEDING FROM THE WHITE ISOLATION PLUG.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277540 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