BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 18249857 · Received December 1, 2023

    Report

    Report Number
    3014704491-2023-00788
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    September 18, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    NA
    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#3171582): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023, AND PACKAGED AT R240 PACKAGE LINE IN JULY 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. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT TESTING: 1) THE NEEDLE PART IS EXAMINED UNDER THE MICROSCOPE, THE NEEDLE TIP AND THE CATHETER TIPPING SHOW NO ABNORMALITY. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTO. 2) LIE DISTANCE TEST, PENETRATION FORCE TEST, NEEDLE REMOVAL FORCE TEST ARE CONDUCTED ON THE SAMPLE, AND THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT (B)(4) FOR THE TEST REPORTS. NO FOREIGN MATTER IS FOUND ON THE REMOVED NEEDLE. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTO. 4. ABOUT THE BLUNTNESS OF THE NEEDLE: MAY BE RELATED TO PRODUCT QUALITY (INCLUDING: LIE DISTANCE, NEEDLE TIP FORCE, CATHETER TIP FORCE, CATHETER DRAG FORCE), PATIENT VASCULAR CONDITIONS, PUNCTURE MANIPULATION. 5. ABOUT THE WHITE TRANSPARENT TUBE FROSTED SURFACE DAMAGE: ACCORDING TO THE LIMITED INFORMATION, WE CAN NOT IDENTIFY THE SPECIFIC PART AND STATE OF THE DAMAGE. IS THE CATHETER TIPPING POOR? 6. ABOUT THE DIFFICULTY OF REMOVING THE NEEDLE: THERE MAY BE RESIDUAL SILICONE BETWEEN THE NEEDLE AND THE SEPTUM.THE SILICONE CONDENSATE MAY LEAD THE SEPTUM AND THE NEEDLE DISENGAGEMENT DIFFICULTY, THEREFOR, THE IFU OF THE PRODUCT INDICATES THAT BEFORE PUNCTURE, HOLD THE PADDLE HUB AND Y-ADAPTER, ROTATE THE PADDLE HUB TO RELEASE THE CATHETER TIP ADHESION, PLEASE SEE ATTACHMENT (B)(4) FOR THE OPERATIONAL VIEW. 7. ABOUT THE UNKNOWN BLACK MATERIAL: THE SOURCE CANNOT BE CONFIRMED BECAUSE WE CANNOT CONDUCT COMPOSITION ANALYSIS OF THE BLACK MATERIAL. 8. 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. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. DUE TO THE INABILITY TO PERFORM RELEVANT TESTS ON DEFECTIVE SAMPLE, THE ROOT CAUSE OF THESE DEFECTS CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 24GAX0.75IN PRN EC SLM NPVC CATHETER WAS DAMAGED ON (B)(6) 2023 17:30 THE NURSE GAVE THE CHILD INTRAVENOUS INFUSION BEFORE THE THREE CHECKS AND NINE PAIRS, OPERATION INTO THE NEEDLE FOUND DISPOSABLE INTRAVENOUS INDWELLING NEEDLE TIP BLUNT, WHITE TRANSPARENT TUBE FROSTED SURFACE BROKEN AND HURT THE CHILD'S SKIN, THE NEEDLE CORE BACK TO THE NEEDLE IS DIFFICULT TO PULL OUT THE NEEDLE BODY THERE IS AN UNKNOWN BLACK MATERIAL, IMMEDIATELY STOP USING AND REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451384 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3171582 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown