BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20893659 · Received December 10, 2024

    Report

    Report Number
    3002601200-2024-00716
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 6, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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#4052009. 1-THE PRODUCTS OF THIS BATCH 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. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND. 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 ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DAMAGED STATE OF THE JOINT BETWEEN THE CATHETER AND THE NEEDLE HUB CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE THERE CANNOT BE CONFIRMED.

    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 24GAX0.75IN PRN EC SLM NPVC LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 6 OCTOBER, WHEN THE NURSE WAS ADMINISTERING AN INFUSION TO A CHILD, THERE WAS A LEAKAGE OF FLUID FROM THE Y-SHAPED PORT OF THE INDWELLING NEEDLE, AND AFTER EXPLAINING THE SITUATION TO THE CHILD'S FAMILY, SHE REMOVED THE CHILD'S INDWELLING NEEDLE AND CONTINUED TO ADMINISTER THE INFUSION AFTER RE-PUNCTURING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502882 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052009 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown