BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 15307857 · Received August 28, 2022

    Report

    Report Number
    1911916-2022-00454
    Event Type
    Malfunction
    Date Received
    August 28, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 9, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: IT WAS REPORTED THE CUSTOMER RECEIVED AN ENTIRE BOX OF 20ML SYRINGES THAT HAVE NO SCALE MARKINGS. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 2152001. THE REVIEW REVEALED THERE WAS DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE PRODUCTION RUN OF THIS BATCH. IT COULD BE POSSIBLE THE PRODUCT RECEIVED WAS AN ESCAPE FROM THE EVENT DETECTED WHILE PRODUCING THIS LOT NUMBER. BASED ON THE INVESTIGATION AND WITH THE DEVICE HISTORY RECORD REVIEW 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 THAT THE BD SYRINGE LUER-LOK¿ TIP WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY RECEIVED AN ENTIRE BOX OF 20 ML SYRINGES THAT HAVE NO MARKINGS ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467540 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2152001 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown