BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE

    MDR report key: 13404515 · Received January 31, 2022

    Report

    Report Number
    1213809-2022-00030
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 12, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11-FEB-2022. H.6. INVESTIGATION: IT WAS REPORTED THAT THE EXPIRATION DATE IS MISSING. THE REPORTED ISSUE IS CONFIRMED. HOWEVER, AT THE TIME OF MANUFACTURING OF THIS BATCH AN EXPIRATION DATE WAS NOT REQUIRED ON THE PRODUCT PACKAGING. BD HAS SINCE THAT TIME IMPLEMENTED A PROCESS FOR ASSIGNING EXPIRATION DATE TO THE PACKAGING. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE THE PRODUCT WAS RECEIVED EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305822 BATCH NO: 5111785. IT WAS REPORTED MISSING EXPIRATION DATE VERBATIM: CUSTOMER RECEIVED PRODUCT THAT HAD A MANUFACTURE DATE OF 2015 AND QUESTIONED WHETHER IT WAS USABLE IT WAS DETERMINED THAT THE SHELF LIFE WAS 5 YEARS, SO THIS PRODUCT IS EXPIRED AND NOT USABLE WE RECEIVED 305822, LOT NO. 5111785 WITH A MANUFACTURING DATE OF 2015/05/28 AND NO EXPIRY DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE THE PRODUCT WAS RECEIVED EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305822. BATCH NO: 5111785. IT WAS REPORTED MISSING EXPIRATION DATE. VERBATIM: CUSTOMER RECEIVED PRODUCT THAT HAD A MANUFACTURE DATE OF 2015 AND QUESTIONED WHETHER IT WAS USABLE IT WAS DETERMINED THAT THE SHELF LIFE WAS 5 YEARS, SO THIS PRODUCT IS EXPIRED AND NOT USABLE WE RECEIVED 305822, LOT NO. 5111785 WITH A MANUFACTURING DATE OF 2015/05/28 AND NO EXPIRY DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE THE PRODUCT WAS RECEIVED EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305822 BATCH NO: 5111785. IT WAS REPORTED MISSING EXPIRATION DATE VERBATIM: CUSTOMER RECEIVED PRODUCT THAT HAD A MANUFACTURE DATE OF 2015 AND QUESTIONED WHETHER IT WAS USABLE IT WAS DETERMINED THAT THE SHELF LIFE WAS 5 YEARS, SO THIS PRODUCT IS EXPIRED AND NOT USABLE WE RECEIVED 305822, LOT NO. 5111785 WITH A MANUFACTURING DATE OF 2015/05/28 AND NO EXPIRY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684535 BD¿ LUER TIP CAP BULK TRAY OF 50, NATURAL COLOR, STERILE LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 5111785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown