BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX0.75IN PRN SLM NPVC

    MDR report key: 19840040 · Received July 26, 2024

    Report

    Report Number
    3002601200-2024-00352
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 30, 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

    DHR/BHR REVIEW LOT#4052015. 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. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. THE CUSTOMER RETURNED 100 UNUSED SAMPLES AND 2 DEFECTIVE SAMPLES WITH BLEEDING AT THE SEPTUM, THE SKU WAS 383078, AND THE BATCH CODE WAS 4052015. THE 800MM SIMULATED CLINICAL LEAKAGE TEST WAS PERFORMED ON 100 SAMPLES, AND 4 PRODUCTS SHOWED LEAKAGE AT THE SEPTUM ABOUT 10 SECONDS AFTER INSERTING THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE DEFECT, CAPA#10442601. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCTION PROCESS, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. A FEW OF THE RETURNED SAMPLES WERE FOUND TO HAVE THE DEFECT OF LEAKAGE AT THE SEPTUM, AND THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX0.75IN PRN SLM NPVC LEAKED. AFTER REMOVING THE INDWELLING NEEDLE, BLOOD SEEPS OUT FROM THE ISOLATION PLUG. THE 100 UNUSED PRODUCTS CAN BE RETURNED. DEFECTIVE PRODUCTS CANNOT BE RETURNED AND CLAIMS ARE REQUIRED. A COMPLAINT REPLY LETTER AND A COMPLAINT RECEIPT LETTER ARE REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485225 BD INTIMA-II 22GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown