BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20385493 · Received October 7, 2024

    Report

    Report Number
    3002601200-2024-00496
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 23, 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

    1. FROM THE FOLLOW-UP INFORMATION: THE PRODUCT WAS IN GOOD CONDITION WITHOUT PHYSICAL DAMAGE OR DEFORMATION BEFORE PUNCTURE; THE FIRST PUNCTURE FAILED, THE BLOOD RETURN WAS FOUND TO BE SLOW WHEN THE PUNCTURE WAS PERFORMED AGAIN, AND NEEDLE THROUGH CATHETER WAS FOUND AFTER THE PRODUCT BEING PULLED OUT. 2. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE FRONT END OF THE CATHETER IS PIERCED BY THE NEEDLE, AND THE NEEDLE HUB IS SLIGHTLY DETACHED FROM THE CATHETER HUB. 3. DHR/BHR REVIEW LOT#4052017 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 2024. WORK ORDER QUANTITY WAS 198,000 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. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE TEST AND PENETRATION FORCE TEST. THE TEST RESULTS SHOW THAT THE LIE DISTANCE, NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE OF THE SAMPLE ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 5. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: 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 TO AVOID MULTIPLE PUNCTURES. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTO SHOWS THAT THE FRONT END OF THE CATHETER IS PIERCED BY THE NEEDLE. SINCE NO ABNORMALITIES ARE FOUND IN THE MANUFACTURING PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TESTING, AND IT IS LEARNED FROM THE FOLLOW-UP INFORMATION THAT NEEDLE THROUGH CATHETER HAS BEEN FOUND AFTER THE SECOND PUNCTURE, IT CANNOT BE DETERMINED THAT THE ROOT CAUSE OF THIS DEFECT IS RELATED TO PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    H.3. 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 INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC NEEDLE THROUGH CATHETER DURING VENIPUNCTURE WITH A CLOSED INTRAVENOUS (IV) NEEDLE, THE FIRST ATTEMPT WAS UNSUCCESSFUL, AND WHEN THE NEEDLE WAS REMOVED, A MISMATCH WAS FOUND BETWEEN THE STEEL NEEDLE OF THE NEEDLE AND THE HOSE, AND THE STEEL NEEDLE PUNCTURED THE HOSE, RESULTING IN FAILURE OF THE PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213585 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052017 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown