BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET

    MDR report key: 14159728 · Received April 20, 2022

    Report

    Report Number
    9610847-2022-00147
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851011
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 385101 AND LOT NUMBER 1113054. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH INSPECTION OF THE SAMPLE, A CRACK WAS OBSERVED ON THE FEMALE CONNECTOR COMPONENT OF THE EXTENSION. WITHIN OUR PRODUCTION PROCESS, THIS TYPE OF DEFECT CANNOT BE REPLICATED; THEREFORE, WE BELIEVE THIS DEFECT COULD BE ATTRIBUTED TO THE RAW MATERIAL USED FOR THE PRODUCT MANUFACTURE OR DUE TO CUSTOMER HANDLING. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET TUBE WAS BROKEN AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE BROKEN, BLOOD LEAKAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ EXTENSION SET TUBE WAS BROKEN AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE BROKEN, BLOOD LEAKAGE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584363 BD Q-SYTE¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385101 1113054 30382903851011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown