BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 20836545 · Received December 3, 2024

    Report

    Report Number
    3002601200-2024-00681
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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 1 PHOTO AND 1 VIDEO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. 1-THE PHOTO SHOWS THAT THE BATCH CODE OF THE SAMPLE IS 4052079. 2-THE VIDEO SHOWS BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4052079 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2-THE SEPTUM INCOMING INSPECTIONS, APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3-THE SEPTUM LEAKAGE TEST RESULTS OF 800PCS IN PROCESS TEST AND 32PCS IN OUTGOING TEST WERE WITHIN THE PRODUCT SPECIFICATIONS. 4-IN THE PRODUCTION PROCESS, THERE IS UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES. 5-THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 1-10PCS OF THE BATCH OF RETAINED SAMPLES WERE TAKEN FOR RELATED TEST: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST RESULTS SHOWED THAT NO LEAKAGE WAS FOUND AT THE SEPTUM. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORTS. 2-THE PLANT HAS LAUNCHED CAPA TO FURTHER INVESTIGATE THE ROOT CAUSE. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCT MANUFACTURING PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, 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 Y 20GAX1.16IN PRN/EC SLM LEAKED DURING USE OF THE PRODUCT, BLOOD SEEPAGE WAS FOUND FROM THE ISOLATION PLUG; THE AFFECTED QUANTITY WAS 1 PLUG, THE SAMPLE COULD NOT BE RETURNED, AND A PHOTO WAS PROVIDED; A GREEN CLAIM IS REQUIRED, A COMPLAINT RESPONSE LETTER IS REQUIRED, AND A COMPLAINT ACCEPTANCE LETTER IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337322 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown