BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20776536 · Received November 25, 2024

    Report

    Report Number
    3002601200-2024-00647
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 13, 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. THE CUSTOMER RETURNS 3 PHOTOS AND 16 ACTUAL SAMPLES (THE SKU IS 383078, AND THE BATCH CODE IS 4052015.). 1. THE PHOTOS SHOW THAT THERE ARE FOREIGN MATTERS AT THE FRONT END OF THE CATHETER AND THE PATIENT'S INSERTION SITE IS RED AND SWOLLEN. 2. ACTUAL SAMPLES SHOW: A. THE UNIT PACKAGE OF 1 SAMPLE HAS BEEN OPENED, IT SEEMS THAT THE SAMPLE HAS BEEN USED. THE SAMPLE IS EXAMINED UNDER A MICROSCOPE WITH 23.1 TIMES MAGNIFICATION, AND IT IS FOUND THAT THERE ARE WATER-LIKE CONDENSATIONS ON THE SURFACE OF THE CATHETER. THE FTIR TEST IS CARRIED OUT ON THE CONDENSATIONS, BUT UNFORTUNATELY, THE RESULT CANNOT BE DETECTED BECAUSE THE CONDENSATIONS ARE TOO SMALL. B. THE UNIT PACKAGE OF THE OTHER 15 SAMPLES ARE NOT OPENED, AND 11 SAMPLES ARE TAKEN FOR STERILITY TEST, AND THE TEST RESULTS MEET THE ACCEPTANCE CRITERIA. THE SURFACE OF THE CATHETER OF THE OTHER 4 SAMPLES IS EXAMINED UNDER A MICROSCOPE WITH 23.1 TIMES MAGNIFICATION, NO FOREIGN MATTERS ARE FOUND, AND THE SILICONE IS VISIBLE. CHECK THE SILICONE WITH THE NAKED EYE, AND THE SILICONE IS INVISIBLE. 2. DHR/BHR REVIE 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. 4. 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 FOREIGN MATTER IS FOUND ON THE SURFACE OF THE CATHETER OF THE RETAINED SAMPLES OF THIS BATCH. 4. ACCORDING TO MA FEEDBACK, THERE ARE MANY FACTORS THAT CAUSE REDNESS, SWELLING 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. CONCLUSION(S): 1. THE RETURNED PHOTOS AND ONE SAMPLE SHOW THAT THERE ARE FOREIGN MATTERS AT THE FRONT OF THE CATHETER. BECAUSE THE UNIT PACKAGE OF THE SAMPLE HAS BEEN OPENED, THE USE OF THE SAMPLE IS UNKNOWN, AND THE FOREIGN MATTERS ARE TOO SMALL TO DETECT THE COMPOSITION, THE SOURCE OF THE FOREIGN MATTERS CANNOT BE DETERMINED. 2. IN ADDITION, THE STERILITY TEST RESULTS OF THE RETURNED 11 SAMPLES MEET THE ACCEPTANCE CRITERIA, NO FOREIGN MATTER IS FOUND ON THE SURFACE OF THE CATHETER OF THE OTHER 4 SAMPLES. 3. NO ABNORMALITIES ARE FOUND IN THE MANUFACTURING PROCESS AND RETAINED SAMPLES, AND THE PRODUCTS MEET THE STERILITY REQUIREMENTS BEFORE RELEASE. 4. IN SUMMARY, THE SOURCE OF THE FOREIGN MATTERS AT THE FRONT OF THE CATHETER CANNOT BE DETERMINED, AND THE REDNESS AND SWELLING OF THE PATIENT'S INSERTION SITE CANNOT BE DETERMINED TO BE RELATED TO PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC HAD FOREIGN MATTER . AFTER UNPACKING, I FOUND A FOREIGN OBJECT. IT IS ORDINARY REHYDRATION SOLUTION AND VITAMINS FOR DENGUE PATIENTS, AND PHLEBITIS HAS OCCURRED THE SAMPLE CAN BE RETURNED, AND PHOTOS ARE AVAILABLE; A GREEN CLAIM IS REQUIRED, A COMPLAINT RESPONSE LETTER IS REQUIRED, AND A RECEIPT IS NOT REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707184 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