BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21047923 · Received December 31, 2024

    Report

    Report Number
    3002601200-2024-00787
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 27, 2024
    Report Date
    February 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830978
    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

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4171646 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JULY 2024, AND PACKAGED AT CFS PACKAGE LINE IN JULY 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 RETURNED. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR HIGH PRESSURE BLASTING TEST, AND THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORTS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PRODUCTION PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO ACTUAL SAMPLE IS RECEIVED TO IDENTIFY THE SPECIFIC LOOSENING SITE AND ABNORMAL STATES, THE ROOT CAUSE OF LOOSENING AND LEAKAGE AFTER HIGH-PRESSURE INJECTION CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00 IN PRN SLM NPVC HP CONNECTOR DEFECTIVE THE PATIENT UNDERWENT BREAST-ENHANCED MRI, AND AFTER INJECTION OF CONTRAST, THE INDWELLING NEEDLE CONNECTION WAS FOUND TO BE LOOSE, THE PATIENT'S BLOOD LEAKED OUT, AND THE MAGNETIC RESONANCE IMAGING WAS CLEAR AND THE CONTRAST INJECTION WAS INTACT

    Description of Event or Problem · 0

    1)WHAT IS THE PRESSURE SETTING OF THE ELECTRIC SYRINGE USED? THE PRESSURE SETTING IS UNKNOWN AND IS PENDING FURTHER CONFIRMATION 2)DOES THE HIGH-PRESSURE INJECTION CAUSE THE ADAPTER TO COME LOOSE? YES 3)IS THERE A LEAK? YES 4)ARE HIGH-PRESSURE SYRINGES OR INFUSION PUMPS USED? YES 5)WHERE DO THE LEAKS MAINLY OCCUR? PATIENT'S CLOTHING 6)IF THERE ARE PHYSICAL OBJECTS/PICTURES/VIDEO SAMPLES, PLEASE PROVIDE THEM THERE ARE NO PHYSICAL OBJECTS, PICTURES, OR VIDEO SAMPLES 7)IS THERE AN IMPACT ON PATIENTS? YES, THE IMPACT WILL BE EXPLAINED LATER. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782443 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171646 00382903830978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown