BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 16550154 · Received March 15, 2023

    Report

    Report Number
    1911916-2023-00148
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    January 31, 2023
    Report Date
    July 22, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE SYRINGES WERE MISSING THE PRINTED LABELS. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE FIRST PHOTO SHOWS AN EMPTY SYRINGE THAT APPEARS TO BE CONNECTED TO A VIAL. THE SECOND PHOTO SHOWS AN EMPTY SYRINGE NEXT TO THE VIAL. FROM THE PHOTOS, IT IS NOT POSSIBLE TO CONFIRM THESE ARE BD SYRINGES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOTS 2021615 AND 2067335. 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. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. THE ACTUAL SAMPLE WOULD ALSO CONFIRM THE SOURCE OF THE PRODUCT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD POSIFLUSH¿ NORMAL SALINE SYRINGES WERE MISSING THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON 31-JAN-2023, ANOTHER COMPLAINT RECORDED (B)(4) WAS OPENED FOR CUSTOMER COMPLAINTS FOR MISSING LABELS ON SYRINGES FOR THE SAME BAXTER FLOSEAL PRODUCT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757969 BD POSIFLUSH¿ NORMAL SALINE SYRINGE INTRAVASCULAR CATHETER FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 2021615 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown