BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20777777 · Received November 26, 2024

    Report

    Report Number
    3002601200-2024-00645
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 2, 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. DHR/BHR REVIEW LOT#4081466 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS PACKAGE LINE IN MAY 2024. WORK ORDER QUANTITY WAS 99,000 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-THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. AS THE PLANT RECEIVED SIMILAR COMPLAINTS FROM OTHER BATCHES OF PRODUCTS, 800MM SIMULATED CLINICAL LEAKAGE TEST WAS CONDUCTED ON THE RETAINED SAMPLES OF THIS BATCH, AND 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. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA 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 LEAKAGE AT SEPTUM NURSES IN THE USE OF SUZHOU BIDI MEDICAL DEVICES CO., LTD. 24G CLOSED-TYPE INTRAVENOUS NEEDLES, FOUND THAT THE 4081466 BATCH OF CLOSED-TYPE INTRAVENOUS NEEDLES FREQUENTLY SEEPAGE OF BLOOD AT THE END OF THE ISOLATION OF THE PHENOMENON, EACH TIME SUCH A SITUATION HAS TO BE RE-LAUNCHED THE NEEDLE TO INCREASE THE RISK OF INFECTION OF THE CHILDREN, WHEN THE REPORT TO THE RELEVANT DEPARTMENTS, THE MANUFACTURER'S REPRESENTATIVE WAS INFORMED OF THE REPLACEMENT OF THIS BATCH OF THE INDWELLING NEEDLES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828718 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown