BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CIT PLH 13X75 2.7 109 USI L-MG CE

    MDR report key: 12333548 · Received August 17, 2021

    Report

    Report Number
    9617032-2021-00889
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD DID RECEIVE 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT, SHOWING ACCEPTABLE DRAW LEVEL. ADDITIONALLY, 20 RETAINED SAMPLES WERE FUNCTIONALLY TESTED AND THE INDICATED FAILURE MODE OF OVERFILL WAS NOT OBSERVED AS ALL RESULTS WERE WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES TEST RESULTS AND PHOTOGRAPHS ATTACHED. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE CIT PLH 13X75 2.7 109 USI L-MG CE THERE WAS OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS "OVERFILLING OF THE TUBE. NOT USABLE FOR ANALYSIS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE TUBE CIT PLH 13X75 2.7 109 USI L-MG CE THERE WAS OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS "OVERFILLING OF THE TUBE. NOT USABLE FOR ANALYSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227145 TUBE CIT PLH 13X75 2.7 109 USI L-MG CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1020146

    Patients

    Seq Age Sex Outcome Treatment
    1