BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19962925 · Received August 12, 2024

    Report

    Report Number
    3002601200-2024-00382
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 14, 2024
    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. DHR/BHR REVIEW LOT-3199702. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN AUGUST 2023, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 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. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-THE PINCH CLAMP BATCH USED IN THIS BATCH OF PRODUCTS IS 3202083, 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 THE SEALING PRESSURE TEST OF THE PINCH CLAMP (PRESSURE UPPER LIMIT 102KPA), AND THE TEST IS PASSED. 4. POSSIBLE CAUSES: THE INDWELLING NEEDLE OF THIS SKU USES THE SMALL PINCH CLAMP. THE BACK END OF THE PINCH CLAMP IS LARGE AND THE CLAMPING PART IS NARROW. AFTER PACKAGING AND STERILIZATION, A PART OF THE EXTENSION TUBING WILL REMAIN BENT. WHEN THE PINCH CLAMP IS IN THE BENT PART OF THE EXTENSION TUBING, IT IS EASY TO CLAMP THE EXTENSION TUBING TO ONE SIDE, RESULTING THE PINCH CLAMP CANNOT FULLY ACT.: CLAMP THE PINCH CLAMP AT THE UNBENT PART OF THE EXTENSION TUBING AND CLAMP THE EXTENSION TUBING IN THE CENTER. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED, THE RELEVANT TESTS CANNOT BE CARRIED OUT, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE FAILURE OF THE PINCH CLAMP 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 INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM WAS DIFFICULT TO CLAMP / UNCLAMP EXT TUBING. ON (B)(6) 2024, WHEN THE NURSE WAS PREPARING FOR INTRAVENOUS INFUSION, SHE FOUND THAT THE INDWELLING NEEDLE CLAMP COULD NOT BE CLAMPED WHEN SHE CONNECTED THE INDWELLING NEEDLE TO THE INFUSION SET FOR EXHAUSTATION, AND THE NURSE IMMEDIATELY REPLACED THE INDWELLING NEEDLE AND REPORTED IT TO THE HEAD NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935211 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3199702 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown