BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 17121256 · Received June 13, 2023

    Report

    Report Number
    1911916-2023-00393
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    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

    H6: INVESTIGATION SUMMARY IT WAS REPORTED SYRINGES HAD DAMAGED PRINT. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH A SCALE MARKING ISSUE AT THE NUMBER TWENTY WITH A MISSING LINE OF THE GRADUATION SCALE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PRINTING PAD DID NOT HAVE ENOUGH PRESSURE INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOT 2243876. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED 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 FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, GA WAS USED AS A PLACE HOLDER BASED OFF USER FACILITY. 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 DURING INSPECTION WITH BD LUER-LOK SYRINGE THE SCALE MARKINGS WERE ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DURING INCOMING INSPECTION WERE DETECTED SAMPLES OF SYRINGE 50ML LL BNS (70124801) WITH DAMAGED PRINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION WITH BD LUER-LOK SYRINGE THE SCALE MARKINGS WERE ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DURING INCOMING INSPECTION WERE DETECTED SAMPLES OF SYRINGE 50ML LL BNS (70124801) WITH DAMAGED PRINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252785 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown