BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    MDR report key: 18980338 · Received March 26, 2024

    Report

    Report Number
    3002601200-2024-00101
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    February 24, 2024
    Report Date
    April 23, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    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 4 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SKU IS 383069, THE BATCH CODE IS 3234085, THE SEPTUM IS DISLODGED , AND BLOOD IS SEEPING FROM THE THE INJECTION HOLE IN THE CATHETER HUB. 2. DHR/BHR REVIEW(LOT#3234085): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN AUGUST 2023, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2023. WORK ORDER QUANTITY WAS (B)(4) 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. SKU#383069 IS A PRODUCT WITH Y PP CONNECTOR, WHICH HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 4. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THE COMPLAINED BATCH, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE SEPTUM. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTOS SHOW A DEFECT OF THE DISLODGEMENT THE SEPTUM. AS NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, THE PRODUCT OF THIS SKU HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, SO THE ROOT CAUSE OF THIS DEFECT MAY BE RELATED TO THE INCORRECT USE OF THE PRODUCT.

    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 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO THE FEBRUARY 24, 2024 EXAMINATION UNDER CT CONTRAST, THE INDWELLING NEEDLE WAS PUSHED WITH A HIGH-PRESSURE SYRINGE DURING THE PUNCTURE PROCEDURE, AND THE INDWELLING NEEDLE EXPERIENCED A DISLODGED PLUG AND SPILLAGE OF THE CONTRAST AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408578 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234085 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown