BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 18659324 · Received February 7, 2024

    Report

    Report Number
    1911916-2024-00061
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    February 2, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED A FLY WAS FOUND TRAPPED IN A SYRINGE. TO AID IN THE INVESTIGATION, FOUR SAMPLES IN SEALED PACKAGING BLISTERS AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. ONE OF THE SAMPLES HAS AN INSECT ADHERED TO THE OUTER WALL OF THE SYRINGE BARREL. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PEST CONTROLS IN PLACE DID NOT DETECT THE INSECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 3139731. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. WE LOGGED AN EXTERNAL DEVIATION ( FORMERLY KNOWN AS A SCAR) REGARDING AN ISSUE THAT OCCURRED CONCERNING ¿A FLY HAS FOUND TRAPPED INSIDE A BECTON DICKINSON SYRINGE, 50ML (KG00031 MFN# (B)(4)) DURING WIPING¿. WE WERE ABLE TO REMOVE THE ITEM FROM OUR STOCK AND THEREFOR HAS LIMITED IMPACT, DURING THE INVESTIGATION IT IS CLASSIFIED AS MINOR. ATTACHED YOU CAN FIND THE REPORT FROM OUR QSM AND TWO IMAGES OF THE INVOLVED SYRINGE AND FLY. COULD YOU PLEASE INVESTIGATE AND PREVENT REOCCURRENCE? RESPONSE TARGET DATE FOR THIS ISSUE IS 23FEB2024.

    Description of Event or Problem · 0

    WE LOGGED AN EXTERNAL DEVIATION ( FORMERLY KNOWN AS A SCAR) REGARDING AN ISSUE THAT OCCURRED CONCERNING ¿A FLY HAS FOUND TRAPPED INSIDE A BECTON DICKINSON SYRINGE, 50ML (KG00031 MNF# 309653) DURING WIPING¿. WE WERE ABLE TO REMOVE THE ITEM FROM OUR STOCK AND THEREFOR HAS LIMITED IMPACT, DURING THE INVESTIGATION IT IS CLASSIFIED AS MINOR. ATTACHED YOU CAN FIND THE REPORT FROM OUR QSM AND TWO IMAGES OF THE INVOLVED SYRINGE AND FLY. COULD YOU PLEASE INVESTIGATE AND PREVENT REOCCURRENCE? RESPONSE TARGET DATE FOR THIS ISSUE IS 23FEB2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875095 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON INCORRECT ENTRY 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown