BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21037176 · Received December 30, 2024

    Report

    Report Number
    3002601200-2024-00784
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 15, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830688
    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. DHR/BHR REVIEW LOT # 4142708. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JUNE 2024, AND PACKAGED AT R245 PACKAGE LINE IN JUNE 2024. 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. 2. NO ACTUAL SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORT. 4. CAUSE ANALYSIS: 1- SKU # 383062 IS A PRODUCT WITH Y PP CONNECTOR, WHICH HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 2- ACCORDING TO THE PRODUCT DESIGN, THE PP CONNECTOR CAN BE CONNECTED WITH ISO LUER JOINT, SO IF IT IS CONNECTED WITH NON-ISO LUER JOINT, THERE WILL BE LEAKAGE AT THE CONNECTION. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE INTIMA-II HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, AND NO ACTUAL SAMPLE IS RECEIVED, THE ROOT CAUSE OF THE COMPLAINED DEFECT CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY.

    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 SS PRN SLM NPVC LEAKED WITH POWER INJECTOR. ON (B)(6) 2024, WE RECEIVED A REPORT FROM OUR HOSPITAL'S MEDICAL IMAGING DEPARTMENT THAT WHEN THE INDWELLING NEEDLE WAS RECENTLY USED TO PERFORM A HIGH-PRESSURE INJECTION OF CONTRAST AGENT, THE PATIENT REPORTED THAT THE CONTRAST AGENT WAS LEAKING OUT OF THE CONNECTOR OF THE INFUSION SET, AND UPON INSPECTION OF THE INDWELLING NEEDLE CONNECTOR THERE WAS A LARGE AMOUNT OF LEAKAGE, AND THE MALFUNCTION RESULTED IN INSUFFICIENT INPUT OF CONTRAST AGENT, WHICH CAUSED THE PATIENT'S SECOND REPEAT PUNCTURE AND SECOND REPEAT EXPOSURE, AND THE STAFF OF THE MEDICAL IMAGING DEPARTMENT REASSURED THE PATIENT AND REPLACED THE INDWELLING NEEDLE TO RE THE STAFF OF MEDICAL IMAGING DEPARTMENT PACIFIED THE PATIENT AND REPLACED THE INDWELLING NEEDLE TO CARRY OUT CONTRAST AND ENHANCEMENT SCANNING AGAIN. AT THE SAME TIME, THE HOSPITAL HAS CONTACTED THE SUPPLIER COMPANY TO RETURN AND EXCHANGE THIS BATCH OF INDWELLING NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128253 BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4142708 00382903830688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown