BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ Q-SYTE

    MDR report key: 8204504 · Received December 28, 2018

    Report

    Report Number
    9610847-2018-00451
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 13, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. THE COMPLAINT WAS DEEMED AS MDR REPORTABLE THEREFORE A SUBMISSION WILL BE PERFORMED. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD¿ Q-SYTE WERE RELATED TO BLOOD STREAM INFECTIONS BY PSEUDOMONAS AERUGINOSA, PSEUDOMONAS LUTEOLA AND STAPHYLOCOCCUS AUREUS. MEDICAL INTERVENTION WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD¿ Q-SYTE WERE RELATED TO BLOOD STREAM INFECTIONS BY PSEUDOMONAS AERUGINOSA, PSEUDOMONAS LUTEOLA AND STAPHYLOCOCCUS AUREUS. MEDICAL INTERVENTION WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT THREE BD¿ Q-SYTE WERE RELATED TO BLOOD STREAM INFECTIONS BY PSEUDOMONAS AERUGINOSA, PSEUDOMONAS LUTEOLA AND STAPHYLOCOCCUS AUREUS. MEDICAL INTERVENTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041196 BD¿ Q-SYTE CATHETER INJECTION PORT FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other