BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 23031168 · Received September 11, 2025

    Report

    Report Number
    1213809-2025-00594
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: A PHOTO OF A LABEL ON A CARTON BOX FOR A 3 ML LL SYRINGE (PART NUMBER 301073, BATCH 5188508) WAS RECEIVED AND EVALUATED. THE INVESTIGATION REVEALED THAT THE EXPIRATION DATE WAS INCORRECTLY PRINTED AS 2023-06-30 INSTEAD OF THE CORRECT DATE, 2030-06-30. ALTHOUGH ALL OTHER PRODUCT INFORMATION ON THE LABEL WAS ACCURATE, THE INCORRECT EXPIRATION DATE RENDERED THE LABEL NON-CONFORMING TO PRODUCT SPECIFICATIONS. THE ROOT CAUSE WAS IDENTIFIED AS A MANUAL ERROR DURING A DATE FORMAT CORRECTION, WHERE THE YEAR WAS MISTAKENLY ENTERED AND THE DISCREPANCY WENT UNDETECTED DURING LABEL VERIFICATION, RESULTING IN THE RELEASE OF THE MISLABELED PRODUCT INTO THE FIELD. IMPORTANTLY, THE CERTIFICATE OF COMPLIANCE REFLECTED THE CORRECT EXPIRATION DATE; PLEASE REFER TO IT FOR ACCURATE DATE INFORMATION. CORRECTIVE ACTIONS INCLUDED PLACING THE BATCH ON GLOBAL HOLD, ISSUING A QUALITY ALERT, AND INITIATING A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INITIATION DETERMINATION (CID). ADDITIONALLY, A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 5188508, WHICH SHOWED (B)(4) QUALITY NOTIFICATION RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301073. LOT #5188508. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED ITEM 301073 FOR OUR PO#(B)(4). THE EXPIRY DATING ON THE CARTON LABELS DOES NOT MATCH THE EXPIRATION DATE ON THE C OF C FOR THIS LOT. PLEASE ADVISE WHICH ONE IS CORRECT. I AM UNSURE OF WHO I SHOULD BE REACHING OUT TO SPECIFICALLY SO I APOLOGIZE IF THIS IS NOT THE CORRECT AUDIENCE. 301073. LOT# 5188508. LABEL EXPIRY DATE: 6/30/2023. C OF C EXPIRY DATE: 6/30/2030. 06/30/2030 IS THE CORRECT EXPIRATION DATE FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233026 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5188508 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown