BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BNS

    MDR report key: 21274050 · Received January 30, 2025

    Report

    Report Number
    1911916-2025-00061
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 8, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010351
    PMA / PMN Number
    UNKNOWN
    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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. BATCH: 4190266, BATCH CREATION DATE: 2024-07-08, BATCH EXPIRATION DATE: 2029-06-30, FULL UDI: (B)(4). BATCH: 3333373, BATCH CREATION DATE: 2023-11-29, BATCH EXPIRATION DATE: 2028-11-30, FULL UDI: (B)(4). BATCH: 4190268, BATCH CREATION DATE: 2024-07-08, BATCH EXPIRATION DATE: 2029-06-30, FULL UDI: (B)(4), BATCH: 4190315, BATCH CREATION DATE: 2024-07-08, BATCH EXPIRATION DATE: 2029-06-30, FULL UDI: (B)(4). BATCH: 4190271, BATCH CREATION DATE: 2024-07-08, BATCH EXPIRATION DATE: 2029-06-30, FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP. IT WAS REPORTED PRINT WAS NOT LEGIBLE ON SYRINGES. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. IN THE PHOTO THERE ARE SIXTEEN SYRINGES. EIGHT OF THE SYRINGES HAVE AN INCOMPLETE '50ML.' THE ADDITIONAL INCOMPLETE LINES OF THE GRADUATION SCALE ARE CONSIDERED AN ACCEPTABLE IMPERFECTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOTS 4228297, 4214927, 4190330, 4190341, 4190352, 4190266, 3333373, 4190268, 4190315 AND 4190271. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL#: 301035, BATCH#: 4190266, 3333373, 4190268, 4190315, 4190271. RCC RECEIVED A COMPLAINT VIA EMAIL. ISSUE WAS OBSERVED WITH PRINTS NOT BEING LEGIBLE ON SYRINGES OF PBS PART#: IC00912. BOTH THE GRADUATION LINES AND NUMERIC NUMBERS PRINTED ON THE SURFACE OF THE SYRINGES ARE NOT READABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590381 SYRINGE 50ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 4190271 50382903010351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown