BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL EMERALD SYRINGE

    MDR report key: 19016231 · Received April 1, 2024

    Report

    Report Number
    2243072-2024-00486
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 12, 2024
    Report Date
    May 6, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903077571
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A QUALITY ENGINEER INSPECTED THE 01 PHOTOGRAPH OF LOT # 3130862 MATERIAL # 307757 SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS ¿DUST PARTICLE¿ OR ¿FOREIGN MATTER¿. PHYSICAL SAMPLES NOT SUBMITTED FOR EVALUATION. A REVIEW OF OUR RISK MANAGEMENT DOCUMENT WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR SPECIFICATION REQUIREMENTS. THE PHOTO OF EMERALD SYRINGE 5 ML LOT # 3130862 MATERIAL # 307757 RECEIVED AND EVALUATED. THE IMAGE SHOWING 3 SYRINGES IN WHICH SOME WHITE PARTICLES SHOWN INSIDE BARREL. THE SYRINGE IS NOT PACKED , ITS OPEN. INVESTIGATION ON THE RETAINED SAMPLES AT OUR END FOR THE LOT # 3130862 MATERIAL # 307757 CARRIED OUT, BUT THERE WERE NOT ANY DEFECT OF FOREIGN MATTER OR DUST PARTICLE OBSERVED IN RETAINED SAMPLES. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT # 3130862 MATERIAL # 307757. THERE WAS NO REJECTED INSPECTIONS OR QUALITY NOTIFICATIONS DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL EMERALD SYRINGE HAS FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS SOME DUST PARTICALS INSIDE THE SYRINGE AND I HAVE ALREADY RAISED THE COMPLAINT FROM THE SAME ACCOUNT FOR 3ML EMERALD.

    Description of Event or Problem · 0

    THERE IS SOME DUST PARTICALS INSIDE THE SYRINGE AND I HAVE ALREADY RAISED THE COMPLAINT FROM THE SAME ACCOUNT FOR 3ML EMERALD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866259 BD CONVENTIONAL EMERALD SYRINGE SYRINGE,PISTON FMF BECTON DICKINSON 3130862 00382903077571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown