BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ORAL DISPENSING SYRINGE

    MDR report key: 11608852 · Received April 2, 2021

    Report

    Report Number
    1213809-2021-00203
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS DISPLAYED THE TOP OF A BOX WITH ADDITION TAPE APPLIED ACROSS THE BOX AND WAS UNCLEAR IF THE BOX HAD BEEN RESEALED. ONE PHOTO DISPLAYED THE TOP OF THE BOX OPENED AND THREE 100-COUNT 1ML ORAL BAGS INSIDE. THE BAGS WERE FROM BATCH 1005165 (P/N 305217). BASED ON THE EVIDENCE PROVIDED, THE REPORTED DEFECT COULD NOT BE CONFIRMED. THE OUTSIDE OF THE BOX WAS NOT SHOWN, AND IT WAS UNCLEAR IF THE PRODUCT WAS REPACKAGED. FURTHERMORE, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO LABEL ON THE CASE OF BD¿ ORAL DISPENSING SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON PO (B)(4), WE RECEIVED QUANTITY 2 OF 320593 7 BD ORAL SY 5X100 1ML. CLR305217, NDC: (B)(4), BD REF# 305217. THE PACKAGE IS SUPPOSED TO COME CLOSED WITH QUANTITY 5 SY/CS. THE PACKAGING OF THE PRODUCT HAS NO BD LABEL ON THE CASE, AS WELL AS HAS ONLY QUANTITY 3/5 SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504669 BD ORAL DISPENSING SYRINGE LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 1005165

    Patients

    Seq Age Sex Outcome Treatment
    1