BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20362065 · Received October 3, 2024

    Report

    Report Number
    3002601200-2024-00485
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 8, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4052017. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 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-THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4054134, 4054179, 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 FUNCTIONAL TESTING: 45PSI LEAKAGE TEST. THE TEST IS PASSED, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND AT THE PRN. PLEASE SEE THE ATTACHED TEST REPORT. 4. THE PRN IS ONLY SUITABLE FOR NORMAL PRESSURE (I.E., LESS THAN 45PSI, 300KPA) INFUSION. 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 REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE PRN IS ONLY SUITABLE FOR NORMAL PRESSURE INFUSION, THE ROOT CAUSE OF THE SUDDEN BURST OF THE SLEEVE STOPPER OF THE PRN DURING PULSED POSITIVE PRESSURE FLUSHING CANNOT BE DETERMINED TO BE RELATED TO PRODUCT QUALITY.

    Description of Event or Problem · 0

    THE PATIENT WAS CANNULATED INTO THE MEDIAN VEIN OF THE RIGHT ELBOW AT 09:40 ON (B)(6) 2014, AND WHEN THE CHILD WAS GIVEN AN INTRAVENOUS INDWELLING NEEDLE INFUSION AT 09:30 ON AUGUST 19, A PULSATILE POSITIVE PRESSURE FLUSHING OF THE TUBE WAS PERFORMED, AND THE LATEX MATERIAL OF THE INDWELLING NEEDLE'S HEPARIN CAP SUDDENLY BURST, AND SEALING FLUID IMMEDIATELY FLOWED OUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603901 INTIMA-II 24GAX0.75IN PRN SLM NPVC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4052017 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown