BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SALINE SYRINGE FILLED

    MDR report key: 8453945 · Received March 26, 2019

    Report

    Report Number
    1911916-2019-00305
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 13, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K982558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). TWO PHOTOS WERE PROVIDED FOR EVALUATION. THEY SHOW A SYRINGE WITH THE PACKAGING FLOW WRAP. THE SYRINGE HAS THE BARREL LABEL MISSING, THEREFORE FAILURE MODE IS VERIFIED. THIS WAS DUE TO A VARIATION IN THE PLUNGER ROD LABELER MACHINE DURING PRODUCTION AND WAS MISSED BY PERSONNEL. 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. THIS IS THE 1ST COMPLAINT FOR THE LOT# 8223653 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8223653 DURING THE PRODUCTION RUN. THIS WAS DUE TO A VARIATION IN THE PLUNGER ROD LABELER MACHINE DURING PRODUCTION AND WAS MISSED BY PERSONNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD POSIFLUSH¿ SALINE SYRINGE FILLED THE BD POSIFLUSH 5ML, PRODUCT MISSING THE LABEL. THE SYRINGE CAME PACKAGED CORRECTLY (INSIDE THE TRANSPARENT PRIMARY PACKAGING). WHAT IS MISSING IS THE STICKER THAT SURROUNDS THE SYRINGE BARREL, WHERE THE SCALE MARKING AND OTHER INFORMATION IS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246958 BD POSIFLUSH¿ SALINE SYRINGE FILLED FLUSH SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8223653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other