BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21104136 · Received January 8, 2025

    Report

    Report Number
    3002601200-2024-00804
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    November 13, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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#4052031. 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 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. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PRODUCTION PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TESTING, THE ROOT CAUSE OF BLOOD SEEPAGE AT THE PADDLE HUB CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Additional Manufacturer Narrative · 0

    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 REQUEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED CHILD (B)(6) WAS ADMITTED TO THE HOSPITAL AT 06:38 ON (B)(6) 2024 FOR ¿COUGH FOR 2 DAYS AND FEVER FOR MORE THAN 3 HOURS¿. PRELIMINARY DIAGNOSIS: 1. ACUTE BRONCHITIS; 2. ACUTE LARYNGITIS; 3. ACUTE TONSILLITIS. OUTPATIENT ORAL ¿CEFACLOR¿ SYMPTOMS IMPROVED, OUTPATIENT COMPLETE BLOOD ROUTINE BACK TO SHOW NEUTROPHIL CLASSIFICATION RATIO IS SLIGHTLY HIGHER, SUGGESTING THE PRESENCE OF BACTERIAL INFECTION, GIVEN CEFPIRAMIDE INTRAVENOUS ANTI-INFECTION AND OTHER SYMPTOMATIC TREATMENT. AT 09:14 ON (B)(6), THE NURSE ON DUTY FOLLOWED THE DOCTOR'S INSTRUCTION TO GIVE THE CHILD THE USE OF ¿CLOSED INTRAVENOUS NEEDLE¿ PERCUTANEOUS SELECTIVE SUPERFICIAL VENOUS CATHETERIZATION, AFTER THE COMPLETION OF THE OPERATION, READY TO GIVE THE CHILD AN INTRAVENOUS INFUSION OF THE DAY'S PRESCRIPTION, ABOUT 2 MINUTES LATER, FOUND THAT THERE IS BLOOD OOZING OUT OF THE HANDLE OF THE NEEDLE, AND USED FOR THE PIPELINE SEALING THE TUBE OF 0.9% SODIUM CHLORIDE. THE NURSE ON DUTY IMMEDIATELY REMOVED THE DEVICE, REPORTED IT TO THE NURSE MANAGER, AND COMMUNICATED WITH THE CHILD'S FAMILY BEFORE TEMPORARILY STOPPING THE PERCUTANEOUS SELECTIVE SUPERFICIAL VENOUS CANNULATION AND USING THE REGULAR INTRAVENOUS ¿DISPOSABLE INTRAVENOUS INFUSION SET¿ TO INFUSE THE DAY'S FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104347 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown