BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 20052000 · Received August 23, 2024

    Report

    Report Number
    3002601200-2024-00402
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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. DHR/BHR REVIEW LOT#4016704. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN (B)(6) 2024, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 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-THE EXTENSION TUBING BATCH USED IN THIS BATCH OF PRODUCTS IS 3360716, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 5-THE PINCH CLAMP BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4022987, 4022988, 4022989, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN, THE EXTENSION TUBING AND THE CLAMPING PARTS OF THE PINCH CLAMP ARE CHECKED, NO ABNORMALITY IS FOUND. THE SAMPLE IS CARRIED OUT FOR THE PINCH CLAMP SEALING PRESSURE TEST (TEST PROCESS: THE EXTENSION TUBING IS PINCHED BY THE PINCH CLAMP IN THE SAME POSITION FOR MORE THAN (B)(4) TIMES, AND THEN HELD IN THE PINCHED STATE UNDER 800MM PRESSURE DEVICE FOR 3 DAYS). TEST RESULTS: NO LEAKAGE IS FOUND AT THE EXTENSION TUBING. 4. WHEN THE EXTENSION TUBING IS PINCHED TO ONE SIDE AND NOT CENTERED IN THE PINCH CLAMP, THE EXTENSION TUBING MAY BE DAMAGED. 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 THE DEFECTIVE SAMPLE IS NOT RECEIVED, THE DAMAGED AND PINCHED STATE OF THE EXTENSION TUBING CANNOT BE IDENTIFIED, AND THE ROOT CAUSE OF THE DAMAGE OF THE EXTENSION TUBING CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM TUBING CLAMP DEFECTIVE / DEFORMED(B)(6) 2024, THE NURSE FOUND THAT THE INFUSION FOUND THAT THE Y END OF THE INDWELLING NEEDLE EXTENSION TUBE STOP FLOW CLIP BROKEN LEAKAGE, GIVEN TO THE PATIENT TO DO A GOOD JOB OF EXPLAINING, IMMEDIATELY REPLACE THE INDWELLING NEEDLE, FOUND IN A TIMELY MANNER DID NOT CAUSE 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
    1618267 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4016704 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown