BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20866241 · Received December 6, 2024

    Report

    Report Number
    3002601200-2024-00699
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4081466 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS PACKAGE LINE IN MAY 2024. WORK ORDER QUANTITY WAS (B)(4) PCS; 2-THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS; 3-THE LEAKAGE TEST RESULTS OF 400PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS; 4-NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS; 5-THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST. NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORT. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLE. SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED FOR FURTHER TESTING, THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE CHILD DUE TO ACUTE UPPER RESPIRATORY TRACT INFECTION, ON (B)(6) 2024 IN THE PEDIATRIC INFUSION ROOM INTRAVENOUS INFUSION TREATMENT, THE USE OF THE PRODUCT, THE NURSE ROUTINELY OPERATED, PUNCTURE PROCESS FOUND THAT ITS ISOLATION PLUG AT THE LEAKAGE OF BLOOD, IMMEDIATELY TO BE WITHDRAWN, REPLACEMENT, THE SECOND VENOUS PUNCTURE, INCREASING THE PAIN OF THE CHILD.

    Description of Event or Problem · 0

    THE CHILD DUE TO ACUTE UPPER RESPIRATORY TRACT INFECTION, ON (B)(6) 2024 IN THE PEDIATRIC INFUSION ROOM INTRAVENOUS INFUSION TREATMENT, THE USE OF THE PRODUCT, THE NURSE ROUTINELY OPERATED, PUNCTURE PROCESS FOUND THAT ITS ISOLATION PLUG AT THE LEAKAGE OF BLOOD, IMMEDIATELY TO BE WITHDRAWN, REPLACEMENT, THE SECOND VENOUS PUNCTURE, INCREASING THE PAIN OF THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487763 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown