BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 12255018 · Received July 30, 2021

    Report

    Report Number
    1911916-2021-00766
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS ISSUES WITH THE SCALE MARKINGS. TO AID IN THE INVESTIGATION, FIVE SAMPLES WITH NO PACKAGING BLISTERS AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. TWO SAMPLES HAVE EMBEDDED DEGRADED RESIN AND THE OTHER THREE SAMPLES HAVE A SCALE MARKING ISSUE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. FOR THE SCALE MARKING ISSUE, IT COULD BE POSSIBLE A JAM OCCURRED DURING THE PRINTING PROCESS INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBER 9232577. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. VERIFICATION OF THE SETTINGS AND ALIGNMENT OF THE PRINTING PROCESS WAS PERFORMED FINDING EVERYTHING ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOMS REPORTED BY THE CUSTOMER ARE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ SYRINGES HAD FADED/ILLEGIBLE SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "3 SYRINGES WITH FADED / UNREADABLE SCALE MARKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148244 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9232577

    Patients

    Seq Age Sex Outcome Treatment
    1