BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 13317463 · Received January 21, 2022

    Report

    Report Number
    1911916-2022-00015
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 10, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1053007. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28 . DEVICE MANUFACTURE DATE: 2021-02-22. MEDICAL DEVICE LOT #: 1113417. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-23. INVESTIGATION SUMMARY: IT WAS REPORTED THE SCALE MARKINGS ARE FAULTY. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE TWO SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBERS 1053007 AND 1113417. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE 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 · 0

    IT WAS REPORTED THAT 4 BD 20ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCALE OF THE SYRINGES ARE SHOWN TO BE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521124 BD 20ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 SEE H10 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown