BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ORAL 5ML CLEAR

    MDR report key: 9873656 · Received March 24, 2020

    Report

    Report Number
    1213809-2020-00202
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 5ML CLEAR ORAL SYRINGE WAS RECEIVED AND EVALUATED. NO DEFECTS WERE OBSERVED IN THE PHOTO. BASED ON THE VERBATIM, IT APPEARS THE DEVICE WAS POTENTIALLY MISUSED WHEN MEDICATION CAME IN CONTACT WITH THE INK THAT MAY HAVE RESULTED IN THE PATIENT INGESTING IT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTO RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE OF THE 5ML SYRINGES FROM THE PHARMACY FOR THEIR 21 MONTH OLD CHILD' S LIQUID MEDICATION AND THE INK CAME OFF OF IT WHEN IT CAME IN CONTACT WITH THE LIQUID MEDICATION AND LEACHED INTO THE MEDICINE, WHICH THE CUSTOMER BELIEVES THAT THEIR CHILD INGESTED. VERBATIM: FROM PHONE CALL ON (B)(6)2020 17:24:52: RECEIVED MESSAGE FROM REPRESENTATIVE, CONSUMER WAS ON PHONE. REP ATTEMPTED TO TRANSFER CALL, BUT IT WAS NOT SUCCESSFUL. TRIED TO REACH CONSUMER TWICE BUT CALL DID NOT CONNECT. SENT EMAIL TO CONSUMER INFORMING HER I WAS TRYING TO REACH HER. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE OF THE 5ML SYRINGES FROM THE PHARMACY FOR THEIR 21 MONTH OLD CHILD' S LIQUID MEDICATION AND THE INK CAME OFF OF IT WHEN IT CAME IN CONTACT WITH THE LIQUID MEDICATION AND LEACHED INTO THE MEDICINE, WHICH THE CUSTOMER BELIEVES THAT THEIR CHILD INGESTED. VERBATIM: FROM PHONE CALL ON 2020-03-04 17:24:52: RECEIVED MESSAGE FROM REPRESENTATIVE, CONSUMER WAS ON PHONE. REP ATTEMPTED TO TRANSFER CALL, BUT IT WAS NOT SUCCESSFUL. TRIED TO REACH CONSUMER TWICE BUT CALL DID NOT CONNECT. SENT EMAIL TO CONSUMER INFORMING HER I WAS TRYING TO REACH HER. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339512 SYRINGE ORAL 5ML CLEAR LIQUID MEDICATION DISPENSER KYR BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Other