BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Q-SYTE DEVICE

    MDR report key: 11646107 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01068
    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
    VA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 UNSPECIFIED BD Q-SYTE¿ DEVICE LEAKED, AND 1 UNSPECIFIED BD Q-SYTE¿ DEVICE WAS DAMAGED/DEFECTIVE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN EXPERIENCED PARTICULATE EMBOLISM (3), LEAKAGE (1), BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE (1), UNABLE TO BREAK SEAL (3), PACKAGE OPEN (1). ADDITIONAL INFO RELATED TO WHAT LEAKED AND FROM WHERE STATES: "ANTIBIOTICS" " THE SEAL". ADDITIONAL INFO RELATED TO BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "PACKAGE OPEN, PLASTIC CHIPPED"".

    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. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. 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 1 UNSPECIFIED BD Q-SYTE¿ DEVICE LEAKED, AND 1 UNSPECIFIED BD Q-SYTE¿ DEVICE WAS DAMAGED/DEFECTIVE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN EXPERIENCED PARTICULATE EMBOLISM (3), LEAKAGE (1), BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE (1), UNABLE TO BREAK SEAL (3), PACKAGE OPEN (1). ADDITIONAL INFO RELATED TO WHAT LEAKED AND FROM WHERE STATES: "ANTIBIOTICS," " THE SEAL." ADDITIONAL INFO RELATED TO BD Q-SYTE SEPTUM IS DAMAGED/DEFECTIVE STATES: "PACKAGE OPEN, PLASTIC CHIPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542590 UNSPECIFIED BD Q-SYTE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1