BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 8939501 · Received August 28, 2019

    Report

    Report Number
    1911916-2019-00869
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9113775. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-04-23. MEDICAL DEVICE LOT #: 9113796. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-04-23. MEDICAL DEVICE LOT #: 9078608. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2019-03-19. MEDICAL DEVICE LOT #: 9150587. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9161930 MEDICAL DEVICE EXPIRATION DATE: 2022-05-31 DEVICE MANUFACTURE DATE: 2019-06-10 INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. THE PHOTO SHOWS TWO SYRINGES WITH THEIR BARREL LABELS. ONE OF THE SYRINGE BARREL LABELS HAS A BAR CODE WITH A BLACK AREA TOWARDS THE UPPER RIGHT SIDE OF THE BAR CODE. THE BATCH RECORDS HAVE A SAMPLE OF THE BARREL LABEL AND THE PROOF THEY WERE SCANNED AND READABLE. 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 FIRST COMPLAINT FOR LOTS # 9161930, 9078608, 9150587, 9113796, 9113775 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF LOTS # 9161930, 9078608, 9150587, 9113796, 9113775 DURING THIS PRODUCTION RUN. ROOT CAUSE DESCRIPTION: BD WAS UNABLE TO REPLICATE THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL EXPERIENCED LABEL OR PACKAGE SMEARING/PRINT PERMANENCY ILLEGIBLE WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306547, BATCH NO: 9161930, 9078608, 9150587, 9113796, 9113775. EVENT DETAILS: NURSING IS REPORTING A LINE RUNNING THROUGH THE BAR CODES AND ARE UNABLE TO READ. THIS IS AFFECTING MULTIPLE LOT #. 9161930, 9078608, 9150587, 9113796, AND 9113775. UNABLE TO SCAN BAR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732591 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other