BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22347015 · Received June 27, 2025

    Report

    Report Number
    3006948883-2025-00246
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830688
    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. THE CUSTOMER RETURNED A PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTO SHOWED THERE IS A SMALL AMOUNT OF BLOOD ON THE FINGER. 2. DHR/BHR REVIEW (LOT#4142706): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JUN 2024 AND PACKAGED AT R245 PACKAGE LINE IN JUN 2024. WORK ORDER QUANTITY WAS (B)(4) PCS. 2) THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) THE LEAKAGE TEST RESULTS OF 160PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS. 4) NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS. 5) THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. RETAINED SAMPLES WERE TAKEN FOR RELATED TEST: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST RESULTS SHOWED THAT NO LEAKAGE WAS FOUND AT THE SEPTUM. 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. 3) THE IFU OF THE PRODUCT INDICATES THAT SHOULD PUT ON GLOVES BEFORE THE PUNCTURE. 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. THE RETURNED PHOTO SHOWS BLOOD ON THE FINGERS, BUT AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF BLOOD IS BEING DRAWN OUT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC LEAKAGE AT SEPTUM ON (B)(6), FEEDBACK WAS RECEIVED FROM THE EQUIPMENT DEPARTMENT OF NINGBO HANGZHOU BAY HOSPITAL THAT A NURSE IN THE OBSTETRICS WARD OPENED 383068, A CLOSED VENOUS CANNULA, AND FOUND BLOOD COMING OUT WHEN WITHDRAWING THE NEEDLE CONE (SEE PICTURE, THE PATIENT WAS HPV POSITIVE). THE PICTURE PROVIDED BY THE HOSPITAL DID NOT SHOW CONTINUOUS BLEEDING FROM THE ISOLATION PLUG. DUE TO BLOOD EXPOSURE CAUSED BY THE WITHDRAWAL OF THE NEEDLE CONE, THE NURSE REPORTED A PRODUCT ADVERSE EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002956 BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4142706 00382903830688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown