BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ORAL DISPENSING SYRINGE

    MDR report key: 15695486 · Received October 29, 2022

    Report

    Report Number
    1213809-2022-00829
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    October 5, 2022
    Report Date
    January 27, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 16-NOV-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. POTENTIAL ROOT CAUSES FOR THE MIXED PRODUCT DEFECT CAN BE ASSOCIATED WITH INADEQUATE LINE CLEARANCE, PARTS CONTAINMENT ON THE NEIGHBORING PRODUCTION LINE AND POOR DESIGN OF THE PRINTED BARREL HOPPER ON THE ASSEMBLY MACHINE WHICH POTENTIALLY MIXES FROM THE MATERIAL HANDLING SYSTEM. AS CORRECTIVE ACTIONS, QUALITY ALERT WILL BE ISSUED TO MANUFACTURING FACILITY FOR LINE CLEARANCE ACTIVITY AND ADEQUATE PART CONTAINMENTS. RE-DESIGNING ALSO WILL BE PERFORMED FOR PROTECTIVE COVER ON PRINTED BARREL HOPPER ON ASSEMBLY MACHINE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1082858. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIFFERENT SYRINGE WAS FOUND IN THE PACK OF BD¿ ORAL DISPENSING SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO RAISE A SUPPLIER COMPLIANT REGARDING A DIFFERENT MODEL OF SYRINGE FOUND WITHIN AMBER ORAL SYRINGE LOT 1082858."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIFFERENT SYRINGE WAS FOUND IN THE PACK OF BD¿ ORAL DISPENSING SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO RAISE A SUPPLIER COMPLIANT REGARDING A DIFFERENT MODEL OF SYRINGE FOUND WITHIN AMBER ORAL SYRINGE LOT 1082858."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2691700 BD¿ ORAL DISPENSING SYRINGE LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 1082858

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown