BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20137176 · Received September 4, 2024

    Report

    Report Number
    3002601200-2024-00426
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 4, 2024
    Report Date
    September 18, 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. THE CUSTOMER RETURNED 1 PHOTO, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4052017 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 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 CAPA INVESTIGATION 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): THE RETURNED PHOTO SHOWS BLOOD OOZING FROM THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED A CAPA INVESTIGATION 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 THE PATIENT WAS ADMITTED TO OUR DEPARTMENT ON (B)(6) 2024 DUE TO NEONATAL NECROTIZING ENTEROCOLITIS. FOLLOWING THE DOCTOR'S ADVICE, AN INTRAVENOUS CHANNEL WAS ESTABLISHED. THE NURSE PERFORMED ROUTINE OPERATIONS AND THE PUNCTURE WAS SUCCESSFUL. WHEN THE BLOOD WAS RETURNED, IT WAS FOUND THAT THE WHITE ISOLATION PLUG OF THE INDWELLING NEEDLE WAS BLEEDING AND LEAKING, WHICH AFFECTED THE PUNCTURE EFFECT AND INCREASED THE NUMBER OF PUNCTURES. THE PATIENT WAS YOUNG AND PRONE TO INFECTION. AFTER THE INCIDENT, IT WAS IMMEDIATELY REMOVED, BLEEDING WAS STOPPED, AND THE INDWELLING NEEDLE WAS REPLACED FOR PUNCTURE, AND THE ADVERSE EVENT WAS REPORTED. DUE TO THE QUALITY PROBLEM OF THE INDWELLING NEEDLE, THE CHILD WAS PUNCTURED AGAIN, WHICH INCREASED THE PAIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187063 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052017 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown