BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRE-FILLED SALINE SYRINGE

    MDR report key: 17757796 · Received September 15, 2023

    Report

    Report Number
    9616657-2023-00038
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    June 20, 2023
    Report Date
    December 11, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K042061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBER 3026599. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRE-FILLED SALINE SYRINGE LABEL INFORMATION WAS MISSING. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTED PREFILLED SYRINGE DID NOT HAVE LABEL ON IT WAS A BLANK SYRINGE UNABLE TO IDENTIFY WHAT IT WAS IN THE PACK. NO GRADUATION MARKINGS EITHER. ANOTHER SYRINGE WAS FOUND WITH TWO LABELS SO IT APPEARS IT WAS A MISPRINT WITH THE SAME LOT, REF AND EXPIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331199 BD PRE-FILLED SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3026599 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown