BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC

    MDR report key: 19064557 · Received April 8, 2024

    Report

    Report Number
    3002601200-2024-00129
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830558
    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 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SKU IS383055, THE BATCH CODE IS 3080100. 2. DHR/BHR REVIEW(LOT#3080100): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2023, AND PACKAGED AT CFS PACKAGE LINE IN MAY 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#383055 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 REFER TO THE ATTACHED TEST REPORT. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND THE RETURNED PHOTOS SHOW THE SKU AND BATCH CODE OF THE COMPLAINED SAMPLE. AS THE PRODUCT OF THIS SKU HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, SO THE ROOT CAUSE OF THE SEPTUM DISLODGEMENT MAY BE RELATED TO THE WRONG 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

    CUSTOMER PROVIDED THE FOLLOWING INFORMAITON "1) WHAT WAS THE PRESSURE SETTING ON THE POWERED INJECTOR USED? - IT'S ABOUT 300PSI, AND THAT'S WHEN THIS HOSPITAL USES CORONARY ANGIOGRAPHY, AND CORONARY ANGIOGRAPHY HAS HIGHER PRESSURES THAN OTHER LUNG AND ABDOMINAL ANGIOGRAPHY IN CANCER PATIENTS 2) WAS THERE ANY DELAY IN TREATMENT OF THE PATIENT BECAUSE OF THIS EVENT? - NOT SURE 3) ANY PATIENT IMPACT?" - YES, THE SEPTUM WAS RUPTURED, AND THERE WAS EXPOSURE OF BLOOD 4.SAMPLE - SAMPLE PICTURE REFER TO ATTACHMENT NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO THE (B)(6) 2024 CT CONTRAST SUBGRAPHIC EXAMINATION, A SUCCESSFUL PUNCTURE WAS PUSHED WITH A HIGH-PRESSURE SYRINGE, AND THEN DURING THE CT EXAMINATION THE INDWELLING NEEDLE DEVELOPED A DISLODGED PLUG AND THE CONTRAST AGENT SPILLED OUT. THIS TYPE OF INDWELLING NEEDLE HAS BEEN THE SUBJECT OF SIMILAR PROBLEMS ON SEVERAL OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143526 BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080100 00382903830558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown