BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 21284926 · Received January 31, 2025

    Report

    Report Number
    3002601200-2025-00028
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 10, 2025
    Report Date
    March 5, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO RETURNED SAMPLES AND PHOTOS FROM CUSTOMER. 2. DHR/BHR REVIEW LOT#4243811. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEP 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP 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-BATCH OF EXTENSION TUBING IS 4236035, WHOSE INSPECTION RESULT MEETS SPECIFICATION. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR CLAMP FORCE TEST AND THE SEALING PRESSURE TEST OF THE PINCH CLAMP (PRESSURE UPPER LIMIT 102KPA), AND THE TEST IS PASSED. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SAMPLES AND PHOTOS ARE NOT RETURNED, SO DEEPER ANALYSIS CAN¿T BE PERFORMED AND THE ROOT CAUSE CAN'T BE DETERMINED. PLANT WILL CONTINUE TRACKING THIS KIND OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM TUBING CLAMP WAS DEFECTIVE / DEFORMED THE NURSE PLACED A BD NEEDLE IN THE CHILD FOR INFUSION TREATMENT, THE DAY OF THE NEEDLE FOR NORMAL INFUSION, THE SECOND DAY OF THE TUBE FOR INFUSION FOUND THAT THE SMALL CLIP CLIP CLOSED PLACE RUPTURE CAUSED FLUID LEAKAGE, SO REMOVE THIS NEEDLE AGAIN FOR A NEW TUBE FOR INFUSION THERAPY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494210 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4243811 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown