BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 17814068 · Received September 25, 2023

    Report

    Report Number
    1911916-2023-00685
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 29-SEP-2023. IT WAS REPORTED THERE IS NO MEASURING UNIT DOSE ON THE SYRINGE. TO AID IN THE INVESTIGATION, THIRTY-SEVEN SAMPLES AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THIRTY-FOUR SAMPLES CAME IN SEALED PACKAGING BLISTERS AND THREE SAMPLES CAME WITH NO PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED, AND THE SAMPLES ARE MISSING THE SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THREE OPENED SHELF BOXES. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. THIS DEFECT COULD OCCUR IF THE INK RAN OUT DURING THE PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 3110691. 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. VERIFICATION OF THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE INK LEVELS WERE GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD SCALE MARKING MISSING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE BOXES WE¿VE RECEIVED SO FAR WITH THAT LOT NUMBER HAS NO MEASURING UNIT DOSE ON THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD SCALE MARKING MISSING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE BOXES WE¿VE RECEIVED SO FAR WITH THAT LOT NUMBER HAS NO MEASURING UNIT DOSE ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834942 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 3110691 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown