BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21459579 · Received February 25, 2025

    Report

    Report Number
    3002601200-2025-00077
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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 DID NOT RETURN THE SAMPLE, BUT RETURNED 3 PHOTOS. ACCORDING TO THE PHOTOS, THE LOT NUMBER WAS 4171046. THE NEEDLE WAS STILL INSERTED INTO THE SKIN OF THE PATIENT, THE NEEDLE HAD BEEN WITHDRAWN, AND THERE WAS BLOOD ON THE TAIL OF THE PRODUCT 2. PRODUCTION RECORD CHECK (LOT#4171046) : 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN JULY 2024, AND PACKAGED IN CFS PACKAGING LINE IN JULY 2024, WITH 99,000 PIECES OF WORK ORDER. 2) ISOLATED PLUG INCOMING INSPECTION, NO ABNORMAL APPEARANCE AND SIZE, IN LINE WITH THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) 400 LEAKAGE TESTS IN PROCESS TESTING AND 32 LEAKAGE TESTS IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS; 4) IN THE PRODUCTION PROCESS, THERE IS NO CONFORMITY, DEVIATION OR REWORK BEHAVIOR; 5) ISOLATION PLUG ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. CAUSE INVESTIGATION: 1) THE RETAINED SAMPLE OF THIS BATCH WAS TAKEN FOR RELATED TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST PASSED, NO LEAKAGE WAS FOUND AT THE ISOLATION PLUG. 2) THE FACTORY HAS INITIATED CAPA FOR FURTHER ROOT CAUSE INVESTIGATION. CONCLUSION: NO ABNORMALITY WAS FOUND IN THE PRODUCT MANUFACTURING PROCESS, AND ALL TEST RESULTS WERE IN LINE WITH THE REQUIREMENTS OF THE PRODUCT SPECIFICATION. NO SIMILAR COMPLAINTS WERE RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOWED LEAKAGE AT THE ISOLATION PLUG. IN RESPONSE TO THIS DEFECT, THE FACTORY HAS INITIATED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    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 SEPTUM0. IN THE MORNING, THE RESPONSIBLE NURSE USED THIS DEVICE TO PUNCTURE AND LEAVE IN A NEEDLE FOR THE PATIENT TO PREPARE FOR INFUSION. BEFORE INSERTING THE NEEDLE, THE NURSE CHECKED THAT THE APPEARANCE OF THE INDWELLING NEEDLE WAS NORMAL. AFTER INSERTING THE NEEDLE, THE NURSE PULLED OUT THE NEEDLE PLUG AND FOUND THAT THE ISOLATION PLUG WAS NOT CLOSED, AND BLOOD KEPT FLOWING OUT OF THE ISOLATION PLUG. THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED AND HEMOSTASIS WAS PERFORMED. AFTER BEING REASSURED AND GIVEN AN EXPLANATION, THE PATIENT AGREED TO THE REINSERTION OF THE NEEDLE. ALTHOUGH THE INCIDENT DID NOT CAUSE FURTHER HARM TO THE PATIENT, REINSERTION OF THE NEEDLE INCREASED THE PATIENT'S PAIN AND RESULTED IN THE LOSS OF SOME BLOOD (ABOUT 10 ML). ACCORDING TO THE DOCTOR'S ASSESSMENT, THE INCIDENT DID NOT CONSTITUTE SERIOUS HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407031 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171046 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown