BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21733409 · Received March 31, 2025

    Report

    Report Number
    3006948883-2025-00039
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 28, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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 1 PHOTO, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE EXTENSION TUBING IS SEPARATED FROM THE CATHETER HUB, BUT THE SPECIFIC STATES AT THE SEPARATION SITE CANNOT BE IDENTIFIED. 2. DHR/BHR REVIEW LOT#4233013: 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN OCT 2024, AND PACKAGED AT R240 PACKAGE LINE IN OCT 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. 4- THE EXTENSION TUBING BATCHES USED IN THIS BATCH OF PRODUCTS IS 4236034, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. RETAINED SAMPLES OF THIS BATCH ARE TAKEN TO TEST THE PULL STRENGTH BETWEEN THE EXTENSION TUBING AND THE CATHETER HUB. THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT FOR TEST REPORTS. 4. THE EXTENSION TUBING AND THE CATHETER HUB ARE BONDED BY ADHESIVE. DURING THE PRODUCT ASSEMBLY PROCESS, ZONE7.S13 IS EQUIPPED WITH 100% VISUAL INSPECTION SYSTEMS FOR THE ADHESIVE QUANTITY AND THE INSERTION DEPTH OF THE EXTENSION TUBING. THE VISION INSPECTION SYSTEMS ARE CHALLENGED WITH STANDARD SAMPLES EVERYDAY AT 7:00, 19:00 AND WHEN CHANGING GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTIONS. 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 SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS THE SEPARATION OF THE EXTENSION TUBING FROM THE CATHETER HUB. AS THE DEFECTIVE SAMPLE IS NOT RETURNED, THE RELEVANT DETECTION CANNOT BE CARRIED OUT, AND THE DEFECT OCCURRED THE NEXT DAY AFTER USE, DURING WHICH THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE SEPARATION OF THE EXTENSION TUBING FROM THE CATHETER HUB CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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 24GAX0.75IN PRN EC SLM NPVC CATHETER BROKE THE PATIENT WAS GIVEN AN INDWELLING NEEDLE ON (B)(6) 2025 , AND DURING INFUSION ON (B)(6) 2025 , IT WAS DISCOVERED THAT THE PATIENT'S INDWELLING NEEDLE HAD BROKEN, WITH ONLY THE 3M PATCH PORTION OF THE NEEDLE REMAINING, AND THE REST OF THE NEEDLE HAD FALLEN OUT; THE PATIENT'S VASCULAR ACCESS PORT WAS DIRECTLY EXPOSED TO THE AIR, WHICH POSED A RISK OF AIR EMBOLISM AND INFECTION. EXPLAINED TO THE PATIENT AND RE-RETAINED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010172 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233013 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown