BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 10838194 · Received November 13, 2020

    Report

    Report Number
    2243072-2020-01820
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 15, 2020
    Report Date
    May 12, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS/ADDITIONAL INFORMATION: SITE LEGAL NAME (FDA): NOGALES. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT Q-SYTE CLOSED LUER ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE SYTE BREAK INSIDE GREEN CONNECTOR AT THE END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. D.1. MEDICAL DEVICE BRAND NAME: Q-SYTE CLOSED LUER ACCESS DEVICE. D.2. MEDICAL DEVICE CATALOG #: 385100. D.3. MEDICAL DEVICE MANUFACTURER: NOGALES. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). DEV. SERVICED BY A 3RD PARTY? NO. D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2021-03-03. E.1. INITIAL REPORTER FIRST NAME: (B)(6). E.1. INITIAL REPORTER LAST NAME: SPEED. E.1. INITIAL REPORTER PHONE#: (B)(6). F.10. IMDRF ANNEX E GRID: E2403. F.10. IMDRF ANNEX F GRID: F26. F.10. IMDRF ANNEX A GRID: A0401, A0504. G.1. MANUFACTURING LOCATION: NOGALES. G.5. PMA/510(K)#: K013621. H.1. TYPE OF REPORTABLE EVENTS: MALFUNCTION. H.3. DEVICE RETURNED TO MANUFACTURER: YES.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED UNIT WHICH CONSIST OF A HICKMAN DEVICE WITH TRACES OF MEDIA AND SOME TYPE OF COMPONENT INSIDE THE LUER AT THE END OF THE DEVICE. THE TOP BODY OF THE BROKEN COMPONENT WAS NOT RETURNED; THEREFORE, WE WERE UNABLE TO CONFIRM THE IDENTITY OF THE COMPONENT THAT WAS USED. VISUAL AND MICROSCOPIC EVALUATION REVEALED THAT THE COMPONENT/ CONNECTOR HAD BROKEN OFF INSIDE THE LUER OF THE HICKMAN DEVICE, CONFIRMING THE REPORTED DEFECT. THE DAMAGE IN VARIOUS AREAS AT THE END OF THE LUER OF THE HICKMAN DEVICE INDICATED THAT THE DEVICE WAS IMPACTED WITH SOME TYPE OF EXCESSIVE STRESS OR FORCE. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, BD WAS UNABLE TO DETERMINE A DEFINITE ROOT CAUSE SINCE THE ENTIRE COMPONENT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT Q-SYTE CLOSED LUER ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE SYTE BREAK INSIDE GREEN CONNECTOR AT THE END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT Q-SYTE CLOSED LUER ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE SYTE BREAK INSIDE GREEN CONNECTOR AT THE END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION, WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD" Q-SYTE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF INCIDENT / NATURE OF DEVICE DEFECT TEST: ON 5/10/20, EMERGENCY ADMISSION FOR HICKMAN LINE REPAIR DUE TO BDQ-SYTE BREAK INSIDE GREEN CONNECTOR AT THE END OF THE HICKMAN LINE. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NO LONG TERM INJURY TO PATIENT, BUT THIS INCIDENT HAD THE POTENTIAL OF A LIFE THREATENING EVENT. ACTION TAKEN, INCLUDES ANY ACTION BY PATIENT, CARER, HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER, EMERGENCY ADMISSION TO HOSPITAL FOR IMMEDIATE HICKMAN LINE REPAIR, INFUSION STABILIZED BY INSERTION AND USE OF A PERIPHERAL LINE UNTIL HICKMAN LINE ABLE TO BE USED BY OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305625 Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention