BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48 INDIA

    MDR report key: 19169940 · Received April 24, 2024

    Report

    Report Number
    1911916-2024-00277
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE WERE DUST LIKE MATERIALS IN A 20ML SYRINGE PACKAGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A PACKAGING BLISTER TOP WEB. THE OTHER TWO PHOTOS SHOW FOREIGN MATTER IN THE PACKAGING BLISTER. FROM THE PHOTOS, IT IS NOT POSSIBLE TO CONFIRM WHAT TYPE OF FOREIGN MATTER IT IS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303285, LOT 3122489. 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 THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    PRESENCE OF DUST LIKE MATERIALS IN 20ML SYRINGE PACKAGE. WE COULD SEE BLACK, WHITE AND YELLOWISH MATERIAL INSIDE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. PRESENCE OF DUST LIKE MATERIALS IN 20ML SYRINGE PACKAGE. WE COULD SEE BLACK, WHITE AND YELLOWISH MATERIAL INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273282 SYRINGE 20ML LL S/C 48 INDIA SYRINGE, PISTON FMF BECTON DICKINSON 3122489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown