BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA Q-SYTE WHT

    MDR report key: 11698371 · Received April 20, 2021

    Report

    Report Number
    9610847-2021-00171
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 4/8/2021 H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED SIX PHOTOGRAPHS WHICH DISPLAYED THE PRODUCT WITH THE REPORTED LEAKAGE. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE RECEIVED SAMPLE. THE FUNCTIONALITY OF THE SAMPLE WAS TESTED AND DID NOT SHOW NEGATIVE RESULTS OF LEAKAGE. THE COMPONENT OF THE SAMPLE THAT SHOWS DAMAGE IS NOT PART OF THE PRODUCT WHEN SOLD. THE POSSIBLE CAUSE OF THE DAMAGE COULD HAVE BEEN INCORRECT USE OF THE PRODUCT. A REVIEW OF PRODUCTION RECORDS COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTA Q-SYTE WHT EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE OF GENERAL FLUIDS FROM THE SEPTUM OF Q-SYTE. ACCORDING TO THE CUSTOMER'S REPORT, GENERAL FLUIDS, NOT ANTICANCER DRUG, LEAKED FROM THE SEPTUM OF Q-SYTE DURING ITS USE IN PCU. THERE WAS NO HEALTH HAZARD FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTA Q-SYTE WHT EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE OF GENERAL FLUIDS FROM THE SEPTUM OF Q-SYTE. ACCORDING TO THE CUSTOMER'S REPORT, GENERAL FLUIDS, NOT ANTICANCER DRUG, LEAKED FROM THE SEPTUM OF Q-SYTE DURING ITS USE IN PCU. THERE WAS NO HEALTH HAZARD FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590530 CONNECTA Q-SYTE WHT STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1