BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Q-SYTE DEVICE

    MDR report key: 11646076 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01067
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 UNSPECIFIED BD Q-SYTE¿ DEVICES LEAKED, 2 Q-SYTES' SEPTUMS WERE DAMAGED/DEFECTIVE, AND 3 DEVICES HAD FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN EXPERIENCED LEAKAGE (2), BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE (2), FOREIGN MATTER ON DEVICE (3). ADDITIONAL INFORMATION RELATED TO WHAT LEAKED AND FROM WHERE STATES: "IT CAME FROM INSIDE THE TUBE BECAUSE IT WAS NOT LACHED ON PROPERLY" "INSIDE THE TUBE" ADDITIONAL INFORMATION RELATED TO BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "THE VIAL WOULDNT LACH" ADDITIONAL INFORMATION RELATED TO THE IMPACT OF BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: " ADDITIONAL INFORMATION RELATED TO THE IMPACT OF BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "DIDNT CLOSE FULLY" ADDITIONAL INFORMATION RELATED TO THE IMPACT OF FOREIGN MATTER ON DEVICE STATES: "WAS LATCHED LOOSELY"".

    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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL 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 2 UNSPECIFIED BD Q-SYTE¿ DEVICES LEAKED, 2 Q-SYTES' SEPTUMS WERE DAMAGED/DEFECTIVE, AND 3 DEVICES HAD FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN EXPERIENCED LEAKAGE (2), BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE (2), FOREIGN MATTER ON DEVICE (3). ADDITIONAL INFORMATION RELATED TO WHAT LEAKED AND FROM WHERE STATES: "IT CAME FROM INSIDE THE TUBE BECAUSE IT WAS NOT LACHED ON PROPERLY" "INSIDE THE TUBE" ADDITIONAL INFORMATION RELATED TO BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "THE VIAL WOULDNT LACH" ADDITIONAL INFORMATION RELATED TO THE IMPACT OF BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: " ADDITIONAL INFORMATION RELATED TO THE IMPACT OF BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "DIDNT CLOSE FULLY" ADDITIONAL INFORMATION RELATED TO THE IMPACT OF FOREIGN MATTER ON DEVICE STATES: "WAS LATCHED LOOSELY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542778 UNSPECIFIED BD Q-SYTE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1