BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20397214 · Received October 8, 2024

    Report

    Report Number
    3002601200-2024-00499
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 23, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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. TWO BATCHES OF PRODUCTS 4081463 AND 4052016.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED (B)(4) PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS A SPOT OF BLEEDING AT THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4081463. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6)2024 AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. DHR/BHR REVIEW LOT#4052016. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN(B)(6) 2024 AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4. THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM 5. AS THE PLANT RECEIVED SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THESE TWO BATCHES OF PRODUCTS, 800MM SIMULATED CLINICAL LEAKAGE TEST WAS CONDUCTED ON THE RETAINED SAMPLES OF THESE TWO BATCHES, AND IT WAS FOUND THAT A FEW SAMPLES LEAKED AT THE END OF THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS OF THESE TWO BATCHES OF PRODUCTS. THE RETURNED PHOTO SHOWS A SPOT OF BLEEDING AT THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, 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 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM (INTIMA II) WHEN IN USE, BLOOD SEEPS FROM THE ISOLATION PLUG. THE DEFECTIVE PRODUCT CANNOT BE RETURNED. THERE IS A PHOTO. NO CLAIM IS NEEDED. A RESPONSE LETTER TO THE COMPLAINT IS NEEDED. A LETTER ACKNOWLEDGING RECEIPT OF THE COMPLAINT IS NEEDED. TWO BATCHES OF PRODUCTS, A TOTAL OF 3 UNITS, BATCH NUMBER: 4081463, EXPIRATION DATE: 2027/4/28, BATCH NUMBER: 4052016, EXPIRATION DATE: 2027/4/4.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686254 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052016 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown