BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 19205995 · Received April 29, 2024

    Report

    Report Number
    2243072-2024-00576
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A QUALITY ENGINEER INSPECTED THE 1 PHYSICAL SAMPLE AND 01 PHOTOGRAPH OF LOT 2061289 REGARDING THE ITEM #303080 SUBMITTED FOR EVALUATION. ANALYSIS OF THE SAMPLES & PHOTOGRAPH SHOWED THAT THE CONTAMINATION IS VISIBLE IN THE SYRINGE. 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. BASED ON THE RETURN SAMPLES. THE REPORTED ISSUE OF ¿CONTAMINATION¿ WAS CONFIRMED. THE PHOTO OF EMERALD SYRINGE 5ML LOT NO. 2061289 RECEIVED AND EVALUATED. THE IMAGE SHOWING THE CONTAMINATION IS VISIBLE IN THE SYRINGE. QUALITY ENGINEER INVESTIGATE AND DID SIMULATION ON THE RETAINED SAMPLES ON OUR END FOR THE LOT NO. 2061289, ITEM #303080. BUT THERE WAS NOT ANY DEFECT OBSERVED IN RETAINED SAMPLES. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NO. 2061289. ITEM # 303080. THERE WAS NO REJECTED INSPECTIONS OR QUALITY NOTIFICATIONS DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER. ROOT CAUSE : THE LINE OPERATOR AND TECHNICIANS WERE INTERVIEWED FOR THE POSSIBILITY OF DUST FALLING INTO PRODUCT CAVITY. PROBABLE ROOT CAUSE FOR THIS DEFECT WAS FOUND TO BE IMPROPER CLEANING OF SYRINGE LOADERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. THE SYRINGE POCKET HAVE A LOT OF DUST INSIDE AS IT HAS HOLES IN IT AND IT SEEMS ITS THE ONLY SYRINGE SEEMS TO BE HAVING DUST AS THE OTHER SYRINGES ARE IN GOOD CONDITION.

    Description of Event or Problem · 0

    THE SYRINGE POCKET HAVE A LOT OF DUST INSIDE AS IT HAS HOLES IN IT AND IT SEEMS ITS THE ONLY SYRINGE SEEMS TO BE HAVING DUST AS THE OTHER SYRINGES ARE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278412 BD EMERALD SYRINGE INTRAVASCULAR CATHETER FOZ BD MEDICAL, MEDICATION DELIVERY SOLUTIONS 2061289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown