BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 20567905 · Received October 30, 2024

    Report

    Report Number
    3002601200-2024-00568
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    August 22, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    DHR/BHR REVIEW LOT# 3080088: THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) EACH. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED FUNCTIONAL TESTS: PENETRATION FORCE TEST AND NEEDLE REMOVAL FORCE TEST. THE TEST RESULTS SHOW THAT THEY ALL MEET THE PRODUCT SPECIFICATIONS. ATTACHMENT PR#(B)(4) FOR THE TEST REPORTS. NEEDLE THROUGH CATHETER DURING PUNCTURE PROCESS MAY BE RELATED TO THE PRODUCT QUALITY (INCLUDING THE NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE, CATHETER DRAG FORCE AND NEEDLE REMOVAL FORCE), THE SKIN AND VEIN CONDITIONS OF THE PATIENT, AND THE PUNCTURE METHOD. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: BEFORE PUNCTURE, HOLD THE PADDLE HUB AND Y-ADAPTER, ROTATE THE PADDLE HUB TO RELEASE THE CATHETER TIP ADHESION, ATTACHMENT PR#(B)(4) FOR THE OPERATIONAL VIEW. INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE AND CATHETER, DO NOT WITHDRAW THE NEEDLE PREMATURELY, AND DO NOT MULTIPLE PUNCTURES. 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. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED, THE RELEVANT TESTS CANNOT BE CARRIED OUT, AND THE USAGE OF THE SAMPLE IS UNKNOWN, SO THE ROOT CAUSE OF NEEDLE THOUGH CATHETER CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM NEEDLE THROUGH CATHETER ON (B)(6) 2024, AT 08:48 HOURS, THE PATIENT WAS UNDERGOING A PET-CT FOR A RECTAL MALIGNANCY, AND WHILE THE NURSE WAS PLACING TUBES, THE STEEL NEEDLE IN THE INTRAVENOUS (IV) INDWELLING NEEDLE PUNCTURED THE IV INDWELLING NEEDLE HOSE WHEN A CLOSED IV INDWELLING NEEDLE WAS BEING USED, WHICH DID NOT RESULT IN ANY HARM TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042237 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080088 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown