BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20361983 · Received October 3, 2024

    Report

    Report Number
    3002601200-2024-00487
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 29, 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

    1. DHR/BHR REVIEW LOT#4052015 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. DUE TO SIMILAR COMPLAINTS RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, THE PLANT HAS CONDUCTED 800MM SIMULATED CLINICAL LEAKAGE TEST ON THE RETAINED SAMPLES OF THIS BATCH AND FOUND THAT A FEW SAMPLES LEAKED AT THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF NEONATAL HYPERBILIRUBINEMIA, AND ON (B)(6) 2024, THE NURSE'S NORMAL OPERATION WAS TO USE THE CLOSED VENOUS CATHETER TO INFUSE THE PATIENT'S FLUIDS, AND DURING THE INFUSION PROCESS, BLOOD LEAKAGE WAS FOUND AT THE ISOLATION PLUG, AND THE DISCOVERY WAS MADE BY REPLACING THE PATIENT'S FLUIDS IMMEDIATELY WITH A NEW CLOSED VENOUS CATHETER FOR THE SECOND PUNCTURE, AND THE PATIENT WAS STERILIZED WITH ALCOHOL AND IODINE IN THE PROCESS OF THE PUNCTURE AND AFTER THE REPLACEMENT THERE WAS NO ABNORMALITY THAT WOULD ALLOW THE PATIENT TO BE ABLE TO USE IT NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053420 INTIMA-II 24GAX0.75IN PRN SLM NPVC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown