BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 21232305 · Received January 24, 2025

    Report

    Report Number
    3002601200-2025-00011
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 27, 2024
    Report Date
    February 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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. DHR/BHR REVIEW LOT#: 4199365. 1. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUG 2024, AND PACKAGED AT R240 PACKAGE LINE IN AUG 2024. BATCH SIZE IS (B)(4) EA. 2. IN THIS BATCH, 400 PCS WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND 32 PCS 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 4211901 AND 4211902, 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 HAVE BEEN RECEIVED FOR THE COMPLAINT, RETURNED ONE PHOTO, THE PHOTO SHOWS THAT LEAKAGE BE SEEN AT THE BOTTOM OF THE SEPTUM. 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 WAS RETURNED, DEEP ANALYSIS IS UNAVAILABLE, SO THE ROOT CAUSE OF THE LEAKAGE COULD NOT BE CONFIRMED, PLANT WILL CONTINUE TRACKING THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM LEAKAGE AT SEPTUM THE CUSTOMER BELIEVES THAT THE PRODUCT QUALITY IS PROBLEMATIC AND NEEDS TO REPLACE THE SAME BATCH OF CONSUMABLES IT HAS HAPPENED SEVERAL TIMES BEFORE, AND NOW THE CUSTOMER NEEDS TO HAVE A BATCH OF INDWELLING NEEDLES WITH THE SAME BATCH NUMBER LEFT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146097 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4199365 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown