BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21009471 · Received December 23, 2024

    Report

    Report Number
    3002601200-2024-00761
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 19, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE BATCH CODE OF THE SAMPLE IS 4081466 AND DOES NOT SHOW THE BENDING STATE OF THE CATHETER. 2. DHR/BHR REVIEW LOT#4081466. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS PACKAGE LINE IN MAY 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. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: PENETRATION FORCE (INCLUDING NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE) TEST. THE TEST RESULTS SHOW THAT ALL MEET THE PRODUCT SPECIFICATIONS. 4. IT IS RECOMMENDED TO FEED THE CATHETER AT A LOW ANGLE DURING THE PUNCTURE PROCESS TO AVOID CATHETER BENDING. 5. 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. AS NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TESTING, AND THE USE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE BEND IN THE CATHETER CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC CATHETER BENT. THE PATIENT WAS DIAGNOSED WITH MULTIPLE MYELOMA 2 YEARS AND 8 MONTHS AGO. HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR FURTHER TREATMENT OF ¿MULTIPLE MYELOMA¿. ON (B)(6) 2024, WHEN THE PATIENT WAS BEING GIVEN AN INTRAVENOUS INFUSION, THE LIQUID DID NOT DRIP AFTER THE NEEDLE WAS REMOVED. INSPECTION REVEALED THAT THE CLOSED INTRAVENOUS INDWELLING NEEDLE HOSE WAS BENT AND COULD NOT BE USED NORMALLY, CAUSING SECONDARY HARM TO THE PATIENT. A NEW CLOSED INTRAVENOUS INDWELLING NEEDLE WAS IMMEDIATELY REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509923 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown