BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20507596 · Received October 22, 2024

    Report

    Report Number
    3002601200-2024-00540
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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. DHR BHR REVIEW LOT 4081458. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS 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 INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. MATERIAL NUMBER: B5171AAAL, BATCH NUMBER 4022038, 4022054. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE BENDING RESISTANCE TEST OF THE CATHETER AND THE FLOW TEST, AND THE TEST RESULTS SHOW NO ABNORMAL. PLEASE SEE THE ATTACHED TEST REPORTS. 4. THE CATHETER OF BD INDWELLING NEEDLE HAS ALWAYS BEEN PROVIDED BY BD SANDY FACTORY. THE CHARACTERISTICS OF THE CATHETER ARE GOOD BIOCOMPATIBILITY, EXCELLENT BENDING RESISTANCE. 5. IT IS RECOMMENDED TO FEED THE CATHETER AT A LOW ANGLE DURING THE PUNCTURE PROCESS TO AVOID CATHETER BENDING; PROPERLY FIX THE CATHETER DURING THE INDWELLING PROCESS TO AVOID CATHETER BENDING; IF THE CATHETER IS BENT IN THE VEIN, BLOOD CLOTS WILL OCCUR, WHICH WILL CAUSE THE CATHETER TO BECOME CLOGGED AND THE CATHETER TO HAVE CREASE. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSIONS: NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR FURTHER TESTING, THE ROOT CAUSE OF THE CATHETER BENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER KINK . (B)(6) 2024, IN THE PATIENT'S RIGHT FOREARM THICK STRAIGHT, GOOD ELASTICITY OF THE BLOOD VESSELS INTO THE CLOSED-TYPE INTRAVENOUS NEEDLE, PUNCTURE TO AVOID THE JOINTS, THE PLACEMENT OF SMOOTH, SMOOTH INFUSION OF FLUIDS AFTER PLACEMENT OF THE TUBE, THE PATIENT PLACED THE TUBE LIMB MOBILITY IS NOT GREAT, IN (B)(6) 2024 FOR ITS CONNECTION OF LIQUID, FOUND THAT THE LIQUID DOES NOT DRIP, IMMEDIATELY REMOVED THE CLOSED-TYPE INTRAVENOUS NEEDLE, FOUND THAT THE CLOSED-TYPE INTRAVENOUS NEEDLE HOSE REFLEX PHENOMENON, REPLACED WITH A NEW NEEDLE, CAN BE USED NORMALLY, THE PATIENT HAS NOT SEEN ADVERSE REACTIONS. A NEW CLOSED IV INDWELLING NEEDLE WAS REPLACED AND FUNCTIONED NORMALLY, AND THE PATIENT HAD NO ADVERSE EFFECTS FOR THE TIME BEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933085 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown