BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML

    MDR report key: 16219855 · Received January 20, 2023

    Report

    Report Number
    1213809-2023-00022
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BASED ON THE INVESTIGATION AND WITH THE RETURNED PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE LINE CLEARANCE IN THE PACKAGING PROCESS. 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. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML THERE WERE MIXED PRODUCTS IN THE PACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A DIFFERENT MODEL OF SYRINGE FOUND WITHIN AMBER ORAL SYRINGE LOT 1082858.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML THERE WERE MIXED PRODUCTS IN THE PACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A DIFFERENT MODEL OF SYRINGE FOUND WITHIN AMBER ORAL SYRINGE LOT 1082858.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104345 BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown