BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19470985 · Received June 5, 2024

    Report

    Report Number
    3002601200-2024-00229
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BD SUZHOU (MDS)
    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

    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 3199615. 1 THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2023, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2023. 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3 REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4 THE PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 3202499, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR LEAKAGE TEST AND PRN REMOVAL TORQUE TEST, THE LEAKAGE TEST IS QUALIFIED, THERE IS NO LEAKAGE AT THE PRN, AND THE PRN REMOVAL TORQUE IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 4. IN THE ASSEMBLY PROCESS OF PRN, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE EQUIPMENT ALARMS AND REMOVES THE PRODUCT. HOWEVER, ALTHOUGH PRN IS FASTENED TO THE PRODUCT DURING ASSEMBLY, IT MAY COME LOOSE IF IT IS VIBRATED DURING TRANSPORTATION. THEREFORE, THE IFU OF THE PRODUCT INDICATES THAT THE PRN SHOULD BE TIGHTENED BEFORE USE TO PREVENT LEAKAGE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSIONS: NO ABNORMALITY IS FOUND ON PROCESS RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE LEAKAGE AT THE PRN CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. HEPARIN CAP LEAKAGE DURING INFUSION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859073 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3199615 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown