BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 18705951 · Received February 14, 2024

    Report

    Report Number
    2243072-2024-00171
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 25, 2024
    Report Date
    March 1, 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
    OTHER HEALTH CARE PROFESSIONAL
    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 2 PHYSICAL SAMPLES AND 01 PHOTOGRAPH OF LOT 3193661 REGARDING THE ITEM # 307754 SUBMITTED FOR EVALUATION. ANALYSIS OF THE SAMPLES SHOWED THAT THE STOPPER HAS BEEN DETACHED FROM PLUNGER, BUT THE PACKAGING WAS ALSO OPEN. 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 ¿STOPPER MISASSEMBLE¿ FROM PLUNGER WAS NOT CONFIRMED AS THE SYRINGES PACKAGING ARE OPEN AND ROOT CAUSE COULD NOT BE DETERMINED BY THIS. THE PHOTO OF EMERALD SYRINGE 3ML LOT NO. 3193661 RECEIVED AND EVALUATED. THE IMAGE SHOWING 2 SYRINGES WITH BLOOD CONTAMINATION ON IT HAVE STOPPER MISASSEMBLE , ALSO THE NEEDLES ARE ATTACHED ON THE PHOTO WITH SHIELD AND PACKAGING IS OPEN. QUALITY ENGINEER INVESTIGATE AND DID SIMULATION ON THE RETAINED SAMPLES ON OUR END FOR THE LOT NO. 3193661, ITEM # 307754. BUT THERE WERE NOT ANY DEFECT OBSERVED IN RETAINED SAMPLES. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NO. 3193661. ITEM # (B)(4). 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 EMERALD SYRINGE SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM "STOPPER" HAS BEEN "DETACHED" FROM PLUNGER DURING BLOOD DRAWING.

    Description of Event or Problem · 0

    STOPER HAS BEEN DETACH FROM PLUNGER DURING BLOOD DRAWING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443824 BD EMERALD SYRINGE INTRAVASCULAR CATHETER FOZ BD MEDICAL, MEDICATION DELIVERY SOLUTIONS 3193661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown