BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL TIP 1ML

    MDR report key: 9759562 · Received February 26, 2020

    Report

    Report Number
    1911916-2020-00186
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 2, 2020
    Report Date
    February 11, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT CAME IN AN OPEN PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED. THE SCALE MARKING PRINTING IS SKEWED. AFTER THE MOLDING PROCESS THE BARREL GOES TO A SCALE PRINTING PROCESS. IN THIS CASE A JAM MAY HAVE OCCURRED INDUCING THE SKEWED PRINTING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9240251 FOR THIS TYPE OF DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: AFTER THE MOLDING PROCESS THE BARREL GOES TO A SCALE PRINTING PROCESS. IN THIS CASE A JAM MAY HAVE OCCURRED INDUCING THE SKEWED PRINTING. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKING VOLUME IS INCORRECT WITH A BD SYRINGE 50ML LL TIP 1ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE SCALE MARKING VOLUME IS STATED INCORRECT AND CURVED ON THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223263 BD SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9240250 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other