BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18717016 · Received February 15, 2024

    Report

    Report Number
    3002601200-2024-00040
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 20, 2024
    Report Date
    April 5, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903830190
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR/BHR REVIEW(LOT#3080092): THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) EA. 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, THE SPECIFIC SITE WHERE THE INDWELLING NEEDLE LOOSENS AND THE DEFECTS THERE CANNOT BE IDENTIFIED. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 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 DEFECT STATE OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF ITS UNUSABLE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM NEEDLE WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSE WAS READY TO INFUSE FLUIDS INTO THE PATIENT WHEN SHE DISCOVERED THAT THE NEEDLE WAS LOOSE AND COULDN'T BE USED, AND IMMEDIATELY REPLACED IT WITH A NEW ONE. WHEN THE NURSE WAS ABOUT TO GIVE HIM FLUIDS, SHE FOUND THAT THE CONNECTOR OF THE INDWELLING NEEDLE WAS LOOSE AND COULD NOT BE USED, SO SHE IMMEDIATELY REPLACED THE NEEDLE WITH A NEW ONE, WHICH WAS USED NORMALLY AND DID NOT CAUSE ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746060 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3080092 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown