BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20339462 · Received September 30, 2024

    Report

    Report Number
    2243072-2024-01003
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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 BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THE SKU OF THE SAMPLE IS 383033. 2. IT IS LEARNED FROM THE ATTACHMENT THAT THE BATCH CODE OF THE SAMPLE IS 3353666. 3. DHR/BHR REVIEW LOT#3353666. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN FEBRUARY 2024, AND PACKAGED AT CFS PACKAGE LINE IN FEBRUARY 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 RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR PRN TORQUE TEST AND PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING). THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED BECAUSE THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED FROM THE RETURNED PHOTO AND THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED.

    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 CAP LOOSE. (B)(6) 2024, THE PATIENT DUE TO FEMORAL NECK FRACTURE, VENOUS THROMBOSIS IN OUR HOSPITAL ORTHOPAEDIC DEPARTMENT OF HOSPITALIZATION, COMPLIANCE WITH MEDICAL ADVICE FOR THE PATIENT FOR INFUSION THERAPY, THE USE OF THE CLOSED INTRAVENOUS NEEDLE, INFUSION FOUND THAT THE PATIENT'S INDWELLING NEEDLE HEPARIN CAP END OF THE YELLOW CAP OFF, CONSIDER THE INDWELLING NEEDLE BLOOD MAY BE EXPOSED TO THE AIR PRONE TO THE FORMATION OF BLOOD CLOTS, IMMEDIATELY REMOVE THE INDWELLING NEEDLE, RE-INDWELLING NEEDLE FOR THE PATIENT FOR VENOUS PUNCTURE. THE PATIENT'S IV WAS RE-PUNCTURED WITH AN INDWELLING NEEDLE, AND THE INFUSION WENT SMOOTHLY. THIS ADVERSE EVENT CAUSED THE PATIENT TO UNDERGO A SECOND VENEPUNCTURE, WHICH BROUGHT PAIN TO THE PATIENT AND INCREASED THE CHANCES OF VENOUS INJURY AND INFECTION, AS WELL AS INCREASING THE WORKLOAD OF NURSING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40634 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3353666 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown