BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 10860988 · Received November 18, 2020

    Report

    Report Number
    3003152976-2020-00510
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 23, 2020
    Report Date
    January 11, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE HUB WAS OBSERVED TO BE CRACKED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1912007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF THE LOT 1912007 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUAL INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE PRODUCT. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY OF THE DEVICE, VERIFYING THERE IS NO DEFECTS ON THE PRODUCT. RECORDS WERE REVIEWED FOR THE REPORTED LOT AND NOT ISSUES WERE IDENTIFIED. IT IS POSSIBLE A JAM WITHIN THE ASSEMBLY LINE MAY HAVE CREATE THE DAMAGE THAT WAS OBSERVED. GIVEN THE DEVICE AND INSPECTION RECORDS SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE, AND RETAINED SAMPLES OF THE SAME LOT DID NOT SHOW THE REPORTED DEFECT, WE CANNOT VERIFY THIS TO BE TRUE FOR THE PRODUCT REPORTED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPINAL NEEDLE 27GA 3.50 IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THE BASE OF THE SPINAL NEEDLE IS FAULTY; THE BASE OF THE NEEDLE LOOKS PARTLY COMPRESSED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPINAL NEEDLE 27GA 3.50 IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THE BASE OF THE SPINAL NEEDLE IS FAULTY; THE BASE OF THE NEEDLE LOOKS PARTLY COMPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330609 SPINAL NEEDLE 27GA 3.50 IN NEEDLE FMI BECTON DICKINSON, S.A. 1912007

    Patients

    Seq Age Sex Outcome Treatment
    1