BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21009473 · Received December 23, 2024

    Report

    Report Number
    3002601200-2024-00762
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 27, 2024
    Report Date
    January 20, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 VIDEO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE VIDEO SHOWED THAT THE GAUGE OF THE SAMPLE WAS 20GA AND THERE WAS CONTINUOUS LEAKAGE AT THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4233035 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN SEPTEMBER 2024, AND PACKAGED AT CFS PACKAGE LINE IN SEPTEMBER 2024. WORK ORDER QUANTITY WAS 99,000 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 400PCS 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. 2PCS 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. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED VIDEO SHOWED THAT THERE WAS CONTINUOUS LEAKAGE AT THE END OF THE SEPTUM, AND THE ROOT CAUSE OF THIS DEFECT COULD NOT BE DETERMINED BECAUSE THERE WERE NO ABNORMALITIES IN THE PRODUCTION PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE WAS RECEIVED FOR FURTHER TESTING. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    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), THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AFTER INTRAVENOUS PUNCTURE WITH AN INDWELLING NEEDLE, AND FLUID OOZED FROM THE SEPTUM OF THE INDWELLING NEEDLE. THE PATIENT WAS APOLOGISED TO AND EXPLAINED TO, AND THE INTRAVENOUS PUNCTURE WAS REDONE. (RECENTLY, THERE HAVE BEEN A NUMBER OF SUCH CASES. THE BATCH NUMBER HAS BEEN CHANGED, BUT SUCH CASES STILL OCCUR).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509925 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown