BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19238865 · Received May 3, 2024

    Report

    Report Number
    3002601200-2024-00164
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 17, 2024
    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

    1. DHR/BHR REVIEW(LOT#3199613): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN AUGUST 2023, AND PACKAGED AT R240 PACKAGE LINE IN AUGUST 2023. 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: 3094808, 3083132, 3128016, 3142540). 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND THE SPECIFIC SITE OF THE CATHETER BREAK AND THE STATE OF THE CATHETER BREAK SURFACE CANNOT BE IDENTIFIED. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT BATCH TO CONDUCT THE RELEVANT FUNCTIONAL TESTS OF THE CATHETER. PLEASE SEE THE ATTACHMENT FOR THE TEST REPORTS. 1)THE BENDING RESISTANCE OF THE CATHETER IS TESTED, AND THE TEST IS PASSED. 2)45PSI LEAKAGE TEST IS CARRIED OUT, AND NO LEAKAGE IS FOUND AT THE CATHETER. 3)CATHETER PULL FORCE TEST IS PERFORMED (TO SIMULATE THE HUMAN ENVIRONMENT, THE SAMPLE NEEDS TO BE SOAKED IN WARM WATER AT 37 ° C FOR 72 HOURS BEFORE TESTING), AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. 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, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF CATHETER BREAK CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER DEFECTIVE/DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT AROUND 10 A.M. ON (B)(6) 2024, THE NURSE IN CHARGE FOUND THAT THE INDWELLING NEEDLE HOSE WAS BROKEN DURING VENIPUNCTURE DURING THE INFUSION OF MEDICINE SOLUTION FOR THE PATIENT IN BED 409, SO THE INDWELLING NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277943 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3199613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown