BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE BI-EXTENSION SET

    MDR report key: 11402999 · Received March 3, 2021

    Report

    Report Number
    9610847-2021-00090
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 1, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50382903851633
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: 2021-06-17. H6: INVESTIGATION SUMMARY: A COMPLAINT OF COMPONENT DAMAGE ON THE Q-SYTE WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS PROVIDED BY THE CUSTOMER TO AID IN THE INVESTIGATION OF THIS DEFECT. THROUGH INVESTIGATION, THE CUSTOMER COMPLAINT WAS CONFIRMED. DAMAGE WAS FOUND ON THE Q-SYTE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0121421. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING PROCESS WAS REVIEWED TO SEE WHERE THIS DEFECT COULD HAVE OCCURRED AND THE FAILURE WAS NOT REPLICATED. THE PROBABLE ROOT CAUSE FOR THIS DEFECT IS INCORRECT PRODUCT USE. A QUALITY ALERT HAS BEEN CREATED TO ALERT THE PLANT OF THIS PROBLEM, AND ALL INVOLVED PERSONNEL WERE EMAILED TO BE MADE AWARE OF THIS ISSUE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ BI-EXTENSION SETS CONNECTION TO THE SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "BROKEN 5 ML SYRINGE FROM SET Q-SYTE (OCTOPUS)." "AFTER INVESTIGATING THE COMPLAINT MATERIAL, WE CAME TO THE CONCLUSION THAT IT WAS NOT THE 5ML SYRINGE BUT THE CONNECTION OF ONE OF THE Q SYTES."

    Additional Manufacturer Narrative · 1

    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 THE BD Q-SYTE¿ BI-EXTENSION SETS CONNECTION TO THE SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "BROKEN 5 ML SYRINGE FROM SET Q-SYTE (OCTOPUS)" "AFTER INVESTIGATING THE COMPLAINT MATERIAL, WE CAME TO THE CONCLUSION THAT IT WAS NOT THE 5ML SYRINGE BUT THE CONNECTION OF ONE OF THE Q SYTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299974 BD Q-SYTE BI-EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385163 0121421 50382903851633

    Patients

    Seq Age Sex Outcome Treatment
    1