BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING SET

    MDR report key: 10856027 · Received November 17, 2020

    Report

    Report Number
    2243072-2020-01844
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 30, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    OJA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-11-06 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER'S COMPLAINT OF TUBING DEFECTIVE / DAMAGED COULD NOT BE VERIFIED BASED ON TESTING OF THE SAMPLE. THE SAMPLE EVALUATED IS AN UNIDENTIFIED BD EXTENSION SET WITH FILTER. THE EXTENSION SET WAS VISUALLY INSPECTED WITH NO DEFECTS OR DAMAGES OBSERVED. THE SAMPLE WAS THEN PRIMED WITH NO ISSUE OF AIR IN LINE OR OCCLUSION. THE SAMPLE WAS LEAK TESTED AND THERE WAS NO SIGNS OF LEAKAGE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS NO ISSUES WERE IDENTIFIED WITH THE RETURNED SAMPLE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBING SET EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/ LOT #: UNKNOWN SHOULD I STILL BE CONTACTING YOU WHEN I HAVE A BATCH OF BAD TUBING TO SEND OUT?

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD TUBING SET EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN. BATCH/ LOT #: UNKNOWN. SHOULD I STILL BE CONTACTING YOU WHEN I HAVE A BATCH OF BAD TUBING TO SEND OUT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322858 UNSPECIFIED BD TUBING SET EXTENSION SET OJA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1