BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 24876210 · Received April 14, 2026

    Report

    Report Number
    9614033-2026-00023
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046584
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. MFR REPORT # 9614033-2026-00023 WAS SUBMITTED AS THE SITE LEGAL NAME WAS INCORRECTLY REPORTED AS SAN AGUSTIN IN THE INITIAL MDR SUBMISSION, 3003152976-2026-00124. MFR REPORT # 9614033-2026-00023 WAS SUBMITTED TO UPDATE THE SITE LEGAL NAME TO CUAUTITLAN, AND TO HAVE THE PROPER MFR NUMBER. MEDICAL DEVICE CATALOG # HAS BEEN UPDATED TO 304658.

    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. THIS REPORT IS SUPPLEMENTAL TO PREVIOUSLY SUBMITTED 3003152976-2026-00124. THE PRODUCT ORIGINALLY WAS DETERMINED TO BE MANUFACTURED BY SAN AGUSTIN HOWEVER, IT WAS LATER DETERMINED THAT THE LEGAL MANUFACTURER IS CUAUTITLAN. THIS NEW MDR IS BEING SUBMITTED TO CORRECT THE LEGAL SITE AND TO SUBMIT A MDR UNDER THE CORRECT SITE REGISTRATION NUMBER. A CORRECTION SUPPLEMENTAL WAS SUBMITTED FOR 3003152976-2026-00124 STATING THE CANCELLATION OF THE ORIGINAL MDR.

    Description of Event or Problem · 0

    MATERIAL NUMBER HAS BEEN UPDATED TO 304658.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL NS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302055 . BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY STATE MOISTURE IN SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING MOISTURE IN SYRINGE. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. MEDLINE COMPLAINT #:(B)(4). DEFECT DESCRIPTION:MOISTURE IN SYRINGE. MEDLINE PART #:153240. PRODUCT DESCRIPTION:.SYRINGE 20ML LL BNS. VENDOR PART #:302055. LOT #:UNKNOWN. DATE REPORTED: 1/28/2026. SAMPLE RECEIVED:YES. RESPONSE NEEDED: YES - INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100863 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO UNKNOWN 00382903046584

    Patients

    Seq Age Sex Outcome Treatment
    1