BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21103040 · Received January 8, 2025

    Report

    Report Number
    3002601200-2025-00002
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    UNK
    Adverse Event
    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#4052015. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 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. REVIEW THE BATCH RECORDS, NO MATERIAL, PROCESS CHANGE. THE STERILIZATION PROCESS IS NORMAL, THE BI STERILITY TEST IS PASSED, AND THE EO RESIDUE TEST IS PASSED, THE PRODUCTS MEET THE REQUIREMENT OF BI STERILITY TEST BEFORE RELEASE. 3. NO ACTUAL SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 4. ACCORDING TO MA FEEDBACK, THERE ARE MANY FACTORS THAT CAUSE REDNESS, SWELLING AND PAIN AT THE INSERTION SITE. POSSIBLE RELATED FACTORS INCLUDE: 1-REPEATED INFUSION IN A VEIN, CAUSING PATHOLOGICAL CHANGES SUCH AS DAMAGE HYPERPLASIA, HYPERTROPHY IN THE VASCULAR WALL. 2-THE BLOOD VESSEL PUNCTURED DURING PUNCTURE IS NOT FOUND IN TIME, RESULTING IN DRUG LEAKAGE OR SMALL HEMATOMA. 3-LAX DISINFECTION DURING OPERATION CAUSES INFECTION. 4-SOME DRUGS MAY CAUSE ALLERGIC REACTIONS. 5-EXCESSIVELY HIGH DRUG CONCENTRATIONS, TOO LOW A TEMPERATURE, TOO FAST A DRIP RATE, OR A CHANGE IN THE PLASMA PH BY THE DRUG. 6-THE PHYSICAL REASONS OF THE PATIENT ITSELF. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): DUE TO THERE IS NO ABNORMALITY IN THE PRODUCTION PROCESS, NO MATERIAL OR PROCESS CHANGES; THE STERILIZATION PROCESS IS NORMAL, AND THE PRODUCTS MEET THE REQUIREMENT OF BI STERILITY TEST BEFORE RELEASE; THE COMPLAINED SAMPLE DOES NOT INVOLVE FUNCTIONAL ISSUES SUCH AS PIERCING FORCE, AND THERE ARE NO SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, SO IT CANNOT BE CONFIRMED THAT THIS COMPLAINT IS RELATED TO PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC MAY HAVE CAUSED AN INFECTION THE PATIENT WAS GIVEN A STAY 2 DAYS OF INDWELLING NEEDLE APPEARED RED, SWOLLEN, PAIN IN THE RIGHT FOREARM, RETAINED SECRETION CULTURE FOR STAPHYLOCOCCUS AUREUS, IMMEDIATE ANTIBIOTIC TREATMENT, WOUND STERILE DRESSING DISINFECTION AND BANDAGE TREATMENT, THE PATIENT WAS ASKED TO ELEVATE THE AFFECTED LIMB. IMMEDIATELY REPLACED WITH ANOTHER PRODUCT TREATMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869700 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other