BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 21938361 · Received April 30, 2025

    Report

    Report Number
    9614033-2025-00041
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 11, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    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

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:304657 BATCH#:4233708 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 #: 153239 PRODUCT DESCRIPTION: SYRINGE 10ML LL BNS VENDOR PART #: 304657 LOT #: 4233708 DATE REPORTED: 3/18/2025 SAMPLE RECEIVED: NO. RESPONSE NEEDED: ACKNOWLEDGMENT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356566 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4233708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown