BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21183703 · Received January 17, 2025

    Report

    Report Number
    3002601200-2024-00827
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 27, 2024
    Report Date
    February 14, 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. 1.DHR/BHR REVIEW LOT#4081482. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL, 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL, 2024. BATCH SIZE IS (B)(4) EA. 2-IN THIS BATCH, 400PCS WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND 32PCS IN OUTGOING TEST, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-SEPTUM BATCHES USED IN THIS BATCH ARE 4082691 AND 4082692, REVIEW THE RAW MATERIAL INSPECTION RECORDS, DIMENSION AND APPEARANCE HAVE NO ABNORMALITIES, WHICH BOTH MEET SPECIFICATION. 5-CHECK THE MAINTENANCE RECORD OF THE SEPTUM RELATED ASSEMBLY EQUIPMENT, NO ABNORMAL MAINTENANCE. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR SEPTUM LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PROCESS AND RETAINED SAMPLES, BECAUSE NO SAMPLES AND PHOTOS WERE RETURNED, DEEP ANALYSIS IS UNAVAILABLE, SO THE ROOT CAUSE OF THE LEAKAGE COULD NOT BE CONFIRMED.

    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 BDINTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUM THERE WAS BLOOD LEAKAGE FROM THE ISOLATION PLUG DURING USE. NO CLAIM IS NECESSARY. A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACCEPTANCE LETTER ARE REQUIRED. THE DEFECTIVE PRODUCT CANNOT BE RETURNED, BUT PHOTOS CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145820 BDINTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown