BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21093939 · Received January 7, 2025

    Report

    Report Number
    3002601200-2024-00801
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 25, 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

    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, 1 VIDEO AND 1 DEFECTIVE SAMPLE. 1-THE PHOTO AND THE VIDEO SHOWED THAT THE END OF THE SEPTUM WAS LEAKING BLOOD, AND IT WAS CONSTANTLY LEAKING BLOOD. 2-THE DEFECTIVE SAMPLE SHOWED THAT THE PINHOLE OF THE SEPTUM WAS NOT CLOSED AND LEAKING. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTOS. 2. DHR/BHR REVIEW LOT#4081482 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). 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. CAUSE INVESTIGATION: 1-2PCS 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 SEPTA. PLEASE SEE ATTACHMENT (B)(4) 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 PHOTO, VIDEO AND DEFECTIVE SAMPLE SHOWED THE LEAKAGE AT THE SEPTUM, FOR WHICH 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 Y 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUM THE EMERGENCY NURSE FOUND BLOOD OOZING FROM THE SEPTUM OF THE JINGMA INTRAVENOUS CATHETER AFTER FINISHING INSERTING THE CATHETER INTO THE PATIENT TODAY. THE BLOOD OOZING WAS CONTINUOUS AND THE SEPTUM COULD NOT BE COMPLETELY SEALED. AFTER COMMUNICATING WITH THE CUSTOMER, IT WAS REPORTED THAT THERE HAVE BEEN MULTIPLE CASES OF BLOOD OOZING FROM THE SEPTUM OF THIS BATCH OF INTRAVENOUS CATHETERS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235483 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown