BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 1-1/2IN SB TW

    MDR report key: 11096925 · Received December 30, 2020

    Report

    Report Number
    3002682307-2020-00436
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 200821 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE CANNULA WAS OBSERVED COMPLETELY DETACHED FROM THE HUB COMPONENT, WITH A SMALL AMOUNT OF RESIDUAL ADHESIVE REMAINING ON THE CANNULA. TO FURTHER INVESTIGATE THIS ISSUE, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE VISUALLY INSPECTED AND ALL SAMPLES APPEARED TO HAVE THE CORRECT AMOUNT OF ADHESIVE JOINING THE CANNULA AND THE HUB COMPONENTS, WITH NO SIGNS OF A LOOSE CONNECTION. PULL TESTS WERE ALSO PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATION. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DUE TO AN INCORRECT DOSAGE OF THE ADHESIVE. THIS ERROR COULD OCCUR DURING THE ASSEMBLY PROCESS DUE TO AN ADJUSTMENT OR REPLACEMENT ISSUE WITH THE ADHESIVE NOZZLE. THE NEEDLES ARE INSPECTED DURING THE MANUFACTURING PROCESS FOR SIGNS OF ADHESIVE ERROR AND AUTOMATICALLY REJECTED IF A DEFECT IS IDENTIFIED. THE CAMERA SYSTEM THAT DETECTS THESE POTENTIAL DEFECTS IS CHALLENGED EVERY EIGHT WORKING HOURS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE ARE CONFIDENT THAT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 18GA 1-1/2IN SB TW DISCONNECTED FROM THE BASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER STRIKING A BOTTLE OF MEDICINE, THE NEEDLE DISCONNECTED FROM ITS BASE.

    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 NEEDLE 18GA 1-1/2IN SB TW DISCONNECTED FROM THE BASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER STRIKING A BOTTLE OF MEDICINE, THE NEEDLE DISCONNECTED FROM ITS BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563148 NEEDLE 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 200821

    Patients

    Seq Age Sex Outcome Treatment
    1