BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML BLISTER PACK LUER LOCK TIP GENERAL

    MDR report key: 15480574 · Received September 24, 2022

    Report

    Report Number
    1911916-2022-00525
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 31, 2022
    Report Date
    September 2, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WAS A SCALE MARKING ISSUE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGE BARREL HAS A SCALE MARKING ISSUE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING MANUFACTURING INDUCING THE SYMPTOM REPORTED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 2152960. 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 AND ALIGNMENT WERE CORRECT. 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 RETURNED 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 A BD¿ 20 ML BLISTER PACK LUER LOCK TIP GENERAL THE SCALE MARKINGS HAD ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRADUATION LINES AND HASH MARKS ON THE SIDE OF THE SYRINGE WERE NOT CLEARLY MARKED CAUSING A MEDICATION DRAW ERROR BY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534098 BD¿ 20 ML BLISTER PACK LUER LOCK TIP GENERAL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2152960 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown