BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL BNS

    MDR report key: 18522752 · Received January 16, 2024

    Report

    Report Number
    1911916-2024-00011
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    50382903010290
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED ONE SYRINGE WAS CONTAMINATED. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS OR FOREIGN MATTER OF ANY KIND WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 301031 AND PROVIDED POSSIBLE LOT NUMBERS 3023920, 3023921 AND 3023925. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    B.3: THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4: POSSIBLE LOT NUMBERS INCLUDE 3023920, 3023921, 3023925 AND POSSIBLE EXPIRATION DATES INCLUDE 3023920 01/31/2028, 3023921 01/312028, 3023925 01/312028. H.3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4: POSSIBLE LOT NUMBER DEVICE MANUFACTURE DATES ARE 3023920 01/31/2023, 3023921 02/28/2023, 3023925 02/28/2023.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: (B)(4) BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THEY FOUND ONE SYRINGE WITH CONTAMINATION AND THEY DON¿T KNOW IF IT CAME ON THE RAW OR WAS CREATED DURING OUR PROCESS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING THE PROCESS WE FOUND ONE SYRINGE WITH CONTAMINATION, WE DON¿T KNOW IF IT CAME ON THE RAW OR WAS CREATED DURING OUR PROCESS. THE PURPOSE OF THIS EMAIL IS JUST FOR AWARENESS, I WILL LET YOU KNOW IF WE STILL HAVE THE PART OR IF WE SCRAP IT. ITEM: 301029 SERIAL/LOT NUMBER: (B)(6).

    Description of Event or Problem · 0

    HOLD FOR RW 1.23. IT WAS REPORTED THAT BD SYRINGE 20ML LL BNS CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PROCESS WE FOUND ONE SYRINGE WITH CONTAMINATION, WE DON¿T KNOW IF IT CAME ON THE RAW OR WAS CREATED DURING OUR PROCESS. THE PURPOSE OF THIS EMAIL IS JUST FOR AWARENESS, I WILL LET YOU KNOW IF WE STILL HAVE THE PART OR IF WE SCRAP IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706585 BD SYRINGE 20ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY INCORRECT ENTRY 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown