BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ORAL DISPENSING SYRINGE 1 ML

    MDR report key: 10049248 · Received May 12, 2020

    Report

    Report Number
    1213809-2020-00303
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/1/2020. H.6. INVESTIGATION: TWO OPENED BAGS OF 1ML ORAL SYRINGE PRODUCT WERE RECEIVED. ONE BAG WAS FROM BATCH #8208759 AND ONE FROM BATCH #9150669 (P/N 305217). THE SAMPLES WERE VISUALLY EVALUATED. THE LABELS ON THE BAGS WERE CORRECTLY PRINTED PER THE LABEL DRAWING ON FILE. THERE IS NO EXPIRATION PRINTED ON THIS LABEL PER DESIGN ¿ THIS IS NOT A DEFECT. SINCE THE BAGS WERE OPENED IT COULD NOT BE CONFIRMED WHETHER THE TIP CAP BAG WAS OR WAS NOT PRESENT IN THE SEALED BAGS. NEITHER OF THE TWO RECEIVED BAGS MATCHED THE COMPLAINT BATCH #. THEREFORE, NO DEFECTS COULD BE CONFIRMED FOR BATCH #9232487 SINCE NO SAMPLES WERE RECEIVED FOR THAT BATCH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD¿ ORAL DISPENSING SYRINGES 1 ML EXPERIENCED NO LABEL OR MISSING INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305217, BATCH NO: 9232487. EVENT DESCRIPTION: THERE IS SUPPOSED TO BE SYRINGE CAPS IN THE BAG WITH THE SYRINGES BUT IN BOTH BAGS THERE WERE NO CAPS. THERE IS NO EXPIRATION DATE ON THIS ITEM.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD¿ ORAL DISPENSING SYRINGES 1 ML EXPERIENCED NO LABEL OR MISSING INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305217 BATCH NO: 9232487. EVENT DESCRIPTION: THERE IS SUPPOSED TO BE SYRINGE CAPS IN THE BAG WITH THE SYRINGES BUT IN BOTH BAGS THERE WERE NO CAPS. THERE IS NO EXPIRATION DATE ON THIS ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509752 BD¿ ORAL DISPENSING SYRINGE 1 ML LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 9232487

    Patients

    Seq Age Sex Outcome Treatment
    1 Other