BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 19855804 · Received July 29, 2024

    Report

    Report Number
    3002601200-2024-00356
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 27, 2024
    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

    1. THE CUSTOMER RETURNED 1 PHOTO AND 1 DEFECTIVE SAMPLE. THE DEFECTIVE SAMPLE SHOWS THAT THE SKU IS 383028, THE BATCH CODE IS 4052031, THERE IS BLOOD AT THE SEPTUM, THERE IS NO BLOOD AT THE CONNECTION BETWEEN THE SEPTUM AND THE CATHETER, AND THE PINHOLE OF THE SEPTUM IS CLOSED. 2. DHR/BHR REVIEW LOT#4052031 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. 4. DUE TO SIMILAR COMPLAINTS HAVE BEEN RECEIVED ABOUT OTHER BATCHES OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE DEFECT CONCLUSION(S): THE DEFECTIVE SAMPLE SHOWS THAT THERE IS BLOOD AT THE SEPTUM. DUE TO SIMILAR COMPLAINTS HAVE BEEN RECEIVED ABOUT OTHER BATCHES OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE DEFECT.

    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

    N O ADDITIONAL INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM LEAKED. LEAKAGE OF BLOOD FROM ISOLATION PLUG DURING PUNCTURE IN PAEDIATRICS, 1 DEFECTIVE PRODUCT CAN BE RETURNED, CLAIMS NEED TO BE SETTLED, COMPLAINT RESPONSE LETTER IS REQUIRED, COMPLAINT RECEIPT LETTER IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384600 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052031 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown