BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20953790 · Received December 17, 2024

    Report

    Report Number
    3002601200-2024-00743
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    August 5, 2024
    Report Date
    December 31, 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

    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 400 PCS IN PROCESS TESTING AND 32 PCS 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 SAMPLES OF THIS BATCH ARE TAKEN FOR 800MM SIMULATED CLINICAL LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLES. 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 ON (B)(6) 2024, THE NEW CHINA PEDIATRICS DEPARTMENT USED A BIDI BRAND CLOSE-COUPLED IV NEEDLE TO ASSIST IN THE INTRAVENOUS INFUSION OF NEWBORNS. AFTER THE PUNCTURE OF THE NEEDLE, THE STEEL NEEDLE WAS RETRACTED, AND IT WAS FOUND THAT BLOOD WAS BROUGHT OUT AT THE RETRACTION POINT OF THE STEEL NEEDLE, SO THE USE OF THE NEEDLE WAS SUSPENDED, AND THE NEEDLE WAS REPLACED WITH A NEEDLE FROM ANOTHER BATCH, AND AFTER THE REPLACEMENT, THE PUNCTURE WAS NORMAL WITHOUT ANY IMPACT ON THE NEWBORNS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720116 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown