BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21143272 · Received January 13, 2025

    Report

    Report Number
    3002601200-2024-00817
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 13, 2025
    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 2 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWED THAT THE SKU WAS 383012, THE BATCH CODE WAS 4052079, AND THE LEAKAGE SITE WAS AT 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). PCS; 2-THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS; 3-THE LEAKAGE TEST RESULTS OF 800PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS; 4-NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS; 5-THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 1-10PCS RETAINED SAMPLES OF THIS BATCH 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 PRODUCTION PROCESS, ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. THE RETURNED PHOTOS SHOWED THE LEAKAGE SITE WAS AT THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    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 AT SEPTUM ON (B)()6) 2024, AT 9:30, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN IMAGING PROCEDURE THAT REQUIRED AN INDWELLING INTRAVENOUS NEEDLE, WHICH WAS GIVEN FOR VENIPUNCTURE. IN ACCORDANCE WITH THE PRINCIPLE OF ASEPTIC OPERATION, SUCCESSFULLY PUNCTURE THE INDWELLING NEEDLE INTO THE PATIENT'S VEIN, THE INDWELLING NEEDLE BACK TO THE BLOOD VOLUME IS GOOD, AFFIXED A TRANSPARENT DRESSING AFTER GIVING SALINE TUBE SEALING, FOUND THAT THE END OF THE INDWELLING NEEDLE LEAKAGE OOZING BLOOD, IMMEDIATELY CHECK THE CAUSE, EXCLUDE THE PATIENT'S OWN REASONS, CONSIDER PRODUCT QUALITY, IMMEDIATELY REPLACE THE NEW INDWELLING NEEDLE AND RE-PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516524 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