BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 21480786 · Received February 27, 2025

    Report

    Report Number
    3002601200-2025-00085
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 21, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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

    H.3. 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# 4199365. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUG, 2024, AND PACKAGED AT R240 PACKAGE LINE IN AUG, 2024. BATCH SIZE IS (B)(4) EA. 2-IN THIS BATCH, (B)(4) WERE PERFORMED SEPTUM LEAKAGE TEST IN-PROCESS TEST AND (B)(4) IN OUTGOING TEST, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-SEPTUM BATCHES USED IN THIS BATCH ARE 4211901 AND 4211902, REVIEW THE RAW MATERIAL INSPECTION RECORDS, DIMENSION AND APPEARANCE HAVE NO ABNORMALITIES, WHICH BOTH MEET SPECIFICATION. 5-CHECK THE MAINTENANCE RECORD OF THE SEPTUM RELATED ASSEMBLY EQUIPMENT, NO ABNORMAL MAINTENANCE. 2. THE CUSTOMER RETURNED 1 VIDEO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE VIDEO SHOWED THAT THE GAUGE OF THE SAMPLE WAS 20GA AND THERE WAS CONTINUOUS LEAKAGE AT THE END OF THE SEPTUM. 3. PERFORMED SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED VIDEO SHOWED THAT THERE WAS CONTINUOUS LEAKAGE AT THE END OF THE SEPTUM, AND THE ROOT CAUSE OF THIS DEFECT COULD NOT BE DETERMINED BECAUSE THERE WERE NO ABNORMALITIES IN THE PRODUCTION PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE WAS RECEIVED FOR FURTHER TESTING. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUMA NURSE PERFORMING VENIPUNCTURE ON A PATIENT WITH AN ISOLATION PLUG LEAK DURING A SUCCESSFUL PUNCTURE FOR FLUID INFUSION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED 02/20/2025: -ALL 16 ACCIDENTS WERE RELATED TO A SINGLE LEAK. ADDITIONAL INFORMATION PROVIDED 03/07/2025: -MEDICAL INTERVENTIONS SUCH AS SCREENING ARE NOT REQUIRED BECAUSE BLOOD IS TOUCHED WITH GLOVES AND MEASURES SUCH AS HAND WASHING AND HAND SANITIZATION ARE PERFORMED AFTER EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660613 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4199365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown