BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 20792950 · Received November 27, 2024

    Report

    Report Number
    1213809-2024-00895
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010290
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE PHOTO SHOW TWO SIDES OF TWO BD BULK NON-STERILE BOXES ON TOP OF A PALLET, AND THE OTHER PHOTO SHOWS THE TWO BOXES FROM THE BOX NUMBERS SIDE WITH NUMBERS ¿147¿ VISIBLE AND THE SECOND NUMBER ONLY THE ¿21¿ IS VISIBLE WITH THE THIRD DIGIT CUT-OFF FROM THE PHOTO. BOTH PHOTOS SHOWING NO LABELS AFFIXED TO ANY OF THE BOXES. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BOX LABEL MISSING DEFECT IS ASSOCIATED WITH THE BULK HANDLING PROCESS. RE-TRAINING WILL BE PROVIDED TO RESPONSIBLE ASSOCIATES TO ADDRESS THIS ISSUE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4222991. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS LABEL WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. PO#: (B)(4). MATERIAL#: 301029 / SYRINGE BULK 10ML CS850 / QTY: (B)(4) CASES. REQUESTED DELIVERY DATE 11/01/2024. ISSUE: LABELING ISSUE. ADDITIONAL INFORMATION PROVIDED: OUR CUSTOMER REPORTED ON (B)(6) 2024, THAT TWO/2 BOXES DELIVERED ON VWR PO#: (B)(4) WITHOUT PRODUCT LABELS. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT#: 8257407. THE CORRECT LOT#: 4222991 (I.E., NOT #: 8257407 AS REPORTED BELOW).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844432 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4222991 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown