BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20487007 · Received October 18, 2024

    Report

    Report Number
    3002601200-2024-00533
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 1, 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

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

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THE SLEEVE STOPPER OF THE PRN BULGING. 2. DHR/BHR REVIEW LOT#4109454. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN MAY 2024. WORK ORDER QUANTITY WAS 198,000 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 PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 4113254, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: FLOW TEST AND SELF - TIGHTNESS TEST AFTER PENETRATION (I.E., THE SLEEVE STOPPER OF PRN IS PENETRATED 100 TIMES, AND THE LEAKAGE TEST IS PERFORMED AFTER THE PENETRATIONS). THE TEST RESULTS ALL MEET THE PRODUCT SPECIFICATIONS. 4. ABOUT THE BULGING OF THE SLEEVE STOPPER OF THE PRN: DEFECTS IN RAW MATERIAL OF SLEEVE STOPPER, IMPROPER INSERTION OF THE SMALL END OF SLEEVE STOPPER INTO THE ADAPTER, DRY SURFACE OF THE INFUSION NEEDLE INSERTED INTO THE PRN, INJECTION PRESSURE GREATER THAN 45 PSI AND OTHER FACTORS MAY CAUSE THIS DEFECT. 5. ABOUT THE BLOCKAGE OF THE INDWELLING NEEDLE: THE BLOOD RETURN DURING PUNCTURE IS NORMAL, INDICATING THAT THE INDWELLING NEEDLE ITSELF DOES NOT HAVE THE DEFECT OF BLOCKAGE. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): 1-NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. 2-THE RETURNED PHOTO SHOWS THE SLEEVE STOPPER OF THE PRN BULGING, AND THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED BECAUSE THE DEFECTIVE SAMPLE IS NOT RETURNED FOR FURTHER TESTS. 3-BECAUSE THE BLOOD RETURN WAS NORMAL DURING PUNCTURE, IT CANNOT BE CONFIRMED THAT THE BLOCKAGE IS RELATED TO THE QUALITY OF THE INDWELLING NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM ADAPTER/CONNECTOR DEFECTIVE. ON (B)(6) 2024: WHILE THE NURSE IS PUNCTURING A PATIENT'S IV WITH AN INDWELLING NEEDLE, SHE SEES BLOOD RETURN, BUT THE FLUID IS NOT DRIPPING, AND THE HEPARIN CAP ON THE INDWELLING NEEDLE PROTRUDES OUTWARD WHEN SHE DRAWS BACK WITH A 5 ML SYRINGE AND THEN SLOWLY PUSHES NS. REPLACE IT IMMEDIATELY FOR USE.

    Description of Event or Problem · 0

    FOLLOW-UP LEARNED THAT THE BLOOD RETURN WAS NORMAL DURING THE PUNCTURE OF THE INDWELLING NEEDLE, AND THE POST-BOLUS DRUG SOLUTION COULD NOT BE PUSHED, AND THEN IT WAS FOUND THAT THE HEPARIN CAP WAS BULGING, AND THE RE-BOLUS WAS NORMAL AND UNBLOCKED AFTER THE NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930449 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109454 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown