BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 50 ML SYRINGE STERILE, SINGLE USE

    MDR report key: 14949802 · Received July 7, 2022

    Report

    Report Number
    1911916-2022-00336
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED SOME OF THE SYRINGES WERE MISSING THE SCALE MARKING. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE BARREL PRINTING PROCESS INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2090588. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. 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 WHILE USING BD LUER-LOK¿ 50 ML SYRINGE STERILE, SINGLE USE THE SCALE MARKINGS WERE MISSING. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SOME OF THE SYRINGES WITHIN A CASE OF 50ML LUER-LOK HAD NO MEASUREMENT MARKINGS. SOME OF THE SYRINGES WITHIN A CASE OF 50ML LUER-LOK TIP SYRINGES WERE BLANK AND HAD NO MEASUREMENT MARKINGS. WE ARE AWARE OF 4 DEFECTIVE SYRINGES SO FAR. USER WAS UNABLE TO USE THESE SYRINGES WHEN COMPOUNDING IN THE IV ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371551 BD LUER-LOK¿ 50 ML SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2090588 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown