BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 16503573 · Received March 8, 2023

    Report

    Report Number
    1911916-2023-00127
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 23, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: 30-MAR-2023. TO AID IN THE INVESTIGATION, EIGHT SAMPLES IN A PLASTIC BAG AND SEVEN PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THERE IS ONE PHOTO LABELED 'BLURRY PRINTING.' FROM THE PHOTO IT IS NOT CLEAR IF THERE IS A DEFECT, IMPERFECTION, OR JUST A REFLECTION OF LIGHT WHEN THE PHOTO WAS TAKEN. NONE OF THE SAMPLES RECEIVED HAD BLURRY PRINTING, DEFECTS OR IMPERFECTIONS IN THE SYRINGE SCALE PRINTING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT 2152958. 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. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD LUER-LOK SYRINGE THE SCALE MARKINGS WERE BLURRY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PRODUCTION TEAM ARE CURRENTLY WORKING WITH LOT NUMBER 2152958 WHICH WE RECEIVED 17,000. SOME THAT HAVE UNCLEAR PRINTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD LUER-LOK SYRINGE THE SCALE MARKINGS WERE BLURRY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PRODUCTION TEAM ARE CURRENTLY WORKING WITH LOT NUMBER 2152958 WHICH WE RECEIVED 17,000. SOME THAT HAVE UNCLEAR PRINTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789795 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2152958

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown