BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUNGER ROD

    MDR report key: 16892176 · Received May 8, 2023

    Report

    Report Number
    2243072-2023-00766
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 11, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS LE PONT DE CLAIX, FRANCE. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE EVIDENCE WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS ON APRIL 17TH, 2023. BASED ON THE PROVIDED PICTURE, BDM-PS CAN CONFIRM THE REPORTED CONDITION. THE SHAFT AND THE FLANGE OF THE RED PART SEEM TO HAVE THE SAME DESIGN AND THE SAME DIMENSIONS AS THE AQUA PLUNGER RODS. THE AFFECTED BATCH 2221396 IS A PARENT BATCH MANUFACTURED AT BDM-PS APPROVED. BD SUPPLIER PERFORMED A REVIEW OF THE BATCH HISTORY RECORDS AND DID NOT IDENTIFY ANY NON-CONFORMANCE. THE BATCH INVOLVED IN THIS COMPLAINT MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. THE REPORTED CONDITION IS NOT DETERMINED TO BE CAUSED BY BD. AS A CONSEQUENCE, BDM-PS WILL NOT DEFINE ANY CORRECTIVE AND PREVENTIVE ACTION FOLLOWING THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT IS RECORDED FOR TRENDING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUNGER ROD EXPERIENCED INCORRECT COLOR ON DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DURING THE PACKAGING OF ORDER 3128189 (MIRCERA 100MCG/0.3ML 1ASRG US-WDY, BATCH B3809H02, MAT. NO. 10185667). ON (B)(6) 2023 AT FARCON 6, ON THE LABELING MACHINE CONVEYOR BELT (DIRECTLY AFTER PLACEMENT OF THE READY-TO-USE SYRINGE IN SHUTTLES. DIRECTION NEEDLE FEED) BY CHANCE AN ANOMALY WAS OBSERVED BY THE LINE PERSONNEL. A SHUTTLE WITH FOUR SYRINGES WAS OBSERVED IN WHICH ONE (1) SYRINGE HAD A DIFFERENT PLUNGER COLOR (RED). THE PLUNGER ROD COLOR OF THE ORDER WAS AQUA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUNGER ROD EXPERIENCED INCORRECT COLOR ON DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DURING THE PACKAGING OF ORDER 3128189 (MIRCERA 100MCG/0.3ML 1ASRG US-WDY, BATCH B3809H02, MAT. NO. 10185667) ON (B)(6) 2023 AT FARCON 6, ON THE LABELING MACHINE CONVEYOR BELT (DIRECTLY AFTER PLACEMENT OF THE READY-TO-USE SYRINGE IN SHUTTLES - DIRECTION NEEDLE FEED) BY CHANCE AN ANOMALY WAS OBSERVED BY THE LINE PERSONNEL. A SHUTTLE WITH FOUR SYRINGES WAS OBSERVED IN WHICH ONE (1) SYRINGE HAD A DIFFERENT PLUNGER COLOR (RED). THE PLUNGER ROD COLOR OF THE ORDER WAS AQUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639072 BD ULTRASAFE PLUNGER ROD PISTON SYRINGE FMF BECTON DICKINSON 2221396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown