BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 22GA 1-1/4IN

    MDR report key: 10381581 · Received August 7, 2020

    Report

    Report Number
    3002682307-2020-00244
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    May 7, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-25. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 190416 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 SHELF CARTON WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE LABEL WAS MISSING FROM THE SHELF CARTON. THE LABELS ARE PRINTED WITH THE VARIABLE INFORMATION AND PLACED WITHIN THE SECONDARY PACKAGING MACHINE. THE LABELS ARE PLACED ON THE SHELF CARTONS AND INTRODUCED TO THE SHIPPING CASES THROUGH AN AUTOMATIC PROCESS. THERE IS AN AUTOMATIC DETECTION SYSTEM IN PLACE TO IDENTIFY DEFECTS RELATED TO LABEL ISSUES. THIS DETECTION SYSTEM IS CHALLENGED EVERY EIGHT HOURS. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM A TEMPORARY FAILURE IN THE LABEL FEEDER AND AN ERROR IN WHICH THE FAULTY PRODUCT WAS DETECTED BY THE AUTOMATED DETECTION SYSTEM, BUT WAS NOT PROPERLY REJECTED. IN RESPONSE TO THIS INCIDENT, THE MANUFACTURING TEAM HAS BEEN NOTIFIED OF THIS ISSUE FOR FURTHER AWARENESS ON THE PRODUCTION FLOOR. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS IS ISSUE HAS AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 22GA 1-1/4IN LABEL WAS MISSING THE BATCH NUMBER AND EXPIRATION DATE. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNIT FOUND WITH NO PRODUCT INFORMATION (BATCH NUMBER AND EXPIRY DATE)."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 22GA 1-1/4IN LABEL WAS MISSING THE BATCH NUMBER AND EXPIRATION DATE. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNIT FOUND WITH NO PRODUCT INFORMATION (BATCH NUMBER AND EXPIRY DATE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846952 NEEDLE 22GA 1-1/4IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other