BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ORAL 3ML AMBER

    MDR report key: 11742502 · Received April 28, 2021

    Report

    Report Number
    1213809-2021-00276
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    May 21, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE 3ML ORAL PRODUCT ASSOCIATED WITH THIS COMPLAINT IS MANUFACTURED AND SOLD AS NON-STERILE. THEREFORE, STERILITY TESTING IS NOT APPLICABLE, AND NO DEFECT IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE ORAL 3ML AMBER HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBIAL TESTING OF 3 ML ORAL SYRINGES HAS RETURNED OUT OF SPECIFICATION RESULTS OF 172 CFU/10 SYRINGES (TAMC SPECIFICATION LIMIT 102/10 SYRINGES).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE ORAL 3ML AMBER HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBIAL TESTING OF 3 ML ORAL SYRINGES HAS RETURNED OUT OF SPECIFICATION RESULTS OF 172 CFU/10 SYRINGES (TAMC SPECIFICATION LIMIT 102/10 SYRINGES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632680 SYRINGE ORAL 3ML AMBER LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 0114465

    Patients

    Seq Age Sex Outcome Treatment
    1