BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 21574509 · Received March 11, 2025

    Report

    Report Number
    3002601200-2025-00117
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW (LOT#4171641): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL 2024 AND PACKAGED AT R240 PACKAGE LINE IN JUL 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. 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 BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4149627, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 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. (SEE ATTACHMENT FOR THE TEST REPORT PR# (B)(4)) 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 WILL ALARM AND REMOVE 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. CONCLUSION(S): 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 PRN 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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM LEAKAGE AT DIAPHRAGM PRIOR TO INTRAVENOUS INFUSION, AN INTRAVENOUS NEEDLE WAS PLACED IN THE UPPER LIMB OF THE PATIENT, AND WHEN THE INFUSION WAS PERFORMED, WATER LEAKED FROM THE HEPARIN CAP OF THE NEEDLE, CONTAMINATING THE BED LINEN, AND THE PATIENT WAS DISSATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336546 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171641 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown