BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 21103687 · Received January 8, 2025

    Report

    Report Number
    1911916-2024-00985
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 19, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. BATCH: 4243290, BATCH CREATION DATE: 2024-08-30, BATCH EXPIRATION DATE: 2029-07-31, FULL UDI: (B)(4), BATCH: 4290356, BATCH CREATION DATE: 2024-10-17, BATCH EXPIRATION DATE: 2029-09-30, FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED SYRINGES WERE LEAKING. AS SAMPLES WERE NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW PACKAGING BLISTER TOP WEBS. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOTS 4290356, 4243290 AND 4233037. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL#: 309653, BATCH#: 4290356, 4243290, 4233037. I¿M ONE OF THE BUYERS. I WAS PROVIDED YOUR CONTACT INFO AS OUR REP FOR BD SYRINGES. STAFF HAVE BROUGHT UP A CONCERN WITH SYRINGES THAT ARE LEAKING. THEY HAVE SOME SCREEN SHOTS TO SHOW LOT NUMBERS. I¿VE COPIED XXX OUR MATERIALS COORDINATOR. PLEASE LET US KNOW WHAT OTHER INFO WE CAN PROVIDE. HAS THIS ISSUE BEEN BROUGHT TO YOUR/BD¿S ATTENTION BY OTHER FACILITIES?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235112 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4233037 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown