BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20509252 · Received October 22, 2024

    Report

    Report Number
    3002601200-2024-00543
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 8, 2024
    Report Date
    October 23, 2024
    Manufacturer
    BD SUZHOU (MDS)
    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

    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#4081463 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) 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. 2. NO DEFECTIVE SAMPLE AND PHOTOGRAPH HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE INTERFACE BETWEEN THE SEPTUM AND THE CATHETER HUB. PLEASE SEE THE ATTACHED 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. BECAUSE THE ABNORMAL STATE AT THE INTERFACE BETWEEN THE SEPTUM AND THE CATHETER HUB CANNOT BE IDENTIFIED, THE ROOT CAUSE OF LEAKAGE THERE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT CATHETER JUNCTION. THE CHILD DUE TO ACUTE UPPER RESPIRATORY TRACT INFECTION ON (B)(6) 2024 IN THE PEDIATRIC INFUSION ROOM INFUSION TREATMENT, THE USE OF THE PRODUCT, THE NURSE ROUTINE OPERATION, VENIPUNCTURE FOUND ISOLATION PLUG AND CATHETER SEAT INTERFACE SEEPAGE OF BLOOD OOZE, IMMEDIATELY BE WITHDRAWN, REPLACED, EXPLAINED TO THE FAMILY, THE SECOND VENEPUNCTURE. INCREASED CRYING AND PAIN OF THE CHILD.

    Description of Event or Problem · 0

    INFORMATION PROVIDED ON 10/08. HELLO, NO PHYSICAL PICTURE SAMPLES HAVE BEEN SENT, NO DEFORMATION OF THE CATHETER HAS BEEN FOUND, AND THE HEAD NURSE INFORMED THAT IT IS THE FIRST TIME TO USE, AND LEAKAGE OCCURRED WHEN THE CATHETER WAS PREFILLED BEFORE THE CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566654 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081463 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown