BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21493438 · Received February 28, 2025

    Report

    Report Number
    3002601200-2025-00087
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 15, 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

    1.DHR/BHR REVIEW LOT# 4081482. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APR 2024, AND PACKAGED AT R240 PACKAGE LINE IN APR 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 4082691 AND 4082692, 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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM AND OTHER PARTS OF THE SAMPLE. PLEASE SEE THE ATTACHED TEST REPORTS. 4. POSSIBLE CAUSES: 1-AFTER THE NEEDLE IS PIERCED INTO THE VEIN, THERE IS BLOOD AT THE NOTCH OF THE NEEDLE. IN THE PROCESS OF NEEDLE REMOVAL, ALTHOUGH THE PERFORATION OF THE SEPTUM IS CLOSED, THE BLOOD DROPS IN THE NOTCH WILL BE BROUGHT OUT WITH THE NOTCH. IF THERE IS A LOT OF INERTIA IN THE NEEDLE REMOVAL PROCESS, BLOOD DROPS WILL BE THROWN OUT. 2-IF THE PATIENT'S ARM IS TIED TIGHT DURING THE PUNCTURE, IT WILL CAUSE GREAT PRESSURE IN THE VEIN, AND BLOOD WILL COME OUT WITH THE NEEDLE WHEN THE NEEDLE IS PULLED OUT, BUT THE SUBSEQUENT BLOOD LEAKAGE WILL NOT BE SUSTAINED. 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 ABOUT THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, THE ROOT CAUSE OF LEAKAGE 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 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUM. THIS PRODUCT SUFFERED FROM BLOOD LEAKAGE FROM THE ISOLATION PLUG WHEN THE NEEDLE CORE WAS WITHDRAWN. AFFECTED QUANTITY 1, SAMPLE NOT RETURNABLE, NO PHOTOS AVAILABLE. NO GREEN CLAIM, COMPLAINT RESPONSE LETTER REQUIRED, COMPLAINT RECEIPT LETTER REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665760 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown