BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 26GAX0.56IN PRN SLM PVC

    MDR report key: 20630465 · Received November 7, 2024

    Report

    Report Number
    3002601200-2024-00584
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 19, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND THE STATUS AND COMPOSITION OF THE STAIN AT THE PUNCTURE END OF THE PRN CANNOT BE CONFIRMED. 2. DHR/BHR REVIEW LOT#8043055 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MARCH 2018, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 2018. WORK ORDER QUANTITY WAS 136,000 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. 3. THE SHELF LIFE OF THE INDWELLING NEEDLE IS 3 YEARS. RETAINED SAMPLE ANALYSIS IS NOT PERFORMED AS THE SHELF LIFE OF THIS BATCH OF PRODUCTS HAS EXPIRED. 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 NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. SINCE THE STATUS AND COMPOSITION OF THE STAIN AT THE PUNCTURE END OF THE PRN CANNOT BE CONFIRMED, THE SOURCE OF THE STAIN CANNOT BE DETERMINED.

    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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 26GAX0.56IN PRN SLM PVC HAD FOREIGN MATTER. STAINING ON THE PUNCTURE END OF THE HEPARIN CAP OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47766 BD INTIMA-II Y 26GAX0.56IN PRN SLM PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 8043055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown