BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 21239980 · Received January 27, 2025

    Report

    Report Number
    1911916-2025-00047
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 1, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THERE WAS AN UNKNOWN STAINING AND DISCOLORATION FOUND. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH THREE EMPTY OPENED PACKAGING BLISTERS AND FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL HAS BROWN COLORED SPECKS AROUND THE NUMBER FIFTEEN OF THE GRADUATION SCALE AND AT THE SYRINGE BARREL FLANGE. THE SPECKS ARE EMBEDDED DEGRADED RESIN. THE FOUR PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, POSSIBLE LOT NUMBERS 4325227, 4290252 AND 4152407. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 302832, BATCH NUMBER POTENTIAL#: 4325227 / 4290252 / 4152407. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAD ONE BD SYRINGE THAT WAS CONTAMINATED. IT WOULD HAVE COME FROM ONE OF THE LOT NUMBERS LISTED BELOW. WE ARE NOT EXACTLY SURE WHICH LOT IT CAME FROM BECAUSE WE HAD ONE SYRINGE FROM EACH LOT OPENED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION: 1. WHAT IS THE DATE OF EVENT? (B)(6) 2025. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO EVENTS OR PATIENT HARM OCCURRED; CONTAMINATED SYRINGE NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771743 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown