BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20968278 · Received December 18, 2024

    Report

    Report Number
    3002601200-2024-00754
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    September 25, 2024
    Report Date
    January 15, 2025
    Manufacturer
    BECTON DICKINSON
    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. NO DEFECTIVE SAMPLE OR PHOTO HAS BEEN RECEIVED, THE BENDING SITE, BENDING ANGLE, BENDING DIRECTION OF THE NEEDLE, AND OTHER STATES ABOUT NEEDLE CANNOT BE IDENTIFIED. 2. DHR/BHR REVIEW LOT # 3171581. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023, AND PACKAGED AT R240 PACKAGE LINE IN JULY 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. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BENT NEEDLE IS FOUND. PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. THE BEND IN THE NEEDLE MAY OCCUR IN THE MANUFACTURING PROCESS IN THE PLANT, EXTERNAL TRANSPORTATION PROCESS AND END USE PROCESS. 5. IN APRIL 2024, THE PLANT HAS OPTIMIZED LIE-DISTANCE CAMERA TO SCREEN OUT NEEDLE BENT FROM UPSTREAM PROCESS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON IN THE MANUFACTURING PROCESS AND RETAINED SAMPLES. AS THE STATUS OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE BEND IN THE NEEDLE CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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

    ATTEMPTS TO CONTACT THE CUSTOMER REGARDING WHICH COMPONENT WAS BENT WERE NOT SUCCESSFUL. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER BENT. PATIENT WAS HOSPITALIZED FOR DIABETES MELLITUS AND WAS USING A CLOSED IV INDWELLING NEEDLE FOR INFUSION ON (B)(6)2024 AT 0900 HOURS WHEN THE INDWELLING NEEDLE WAS FOUND TO BE BENT; THE INDWELLING NEEDLE WAS REPLACED AND THE OPERATION CONTINUED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083617 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3171581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown