MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX40 INSTRUMENT; SYSTEM, BLOOD CULTURING

Model Number	442296
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the customer bd bactec¿ fx40 instrument the customer assigned the wrong access number to two bottles from different patients.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "correction of patient data and reassignment of blood culture bottle", "the chemist confused the access numbers and wrongly registered the bottles, she inverted the bottles with the patients, she was helped in the correction process and the problem was solved.No impact for the patients".
Additional Manufacturer Narrative
H.6 investigation summary : a complaint of "correction of patient data and reassignment of blood culture bottle¿ was received against instrument bactec fx40 packaged material number: 442296, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was reassigned the blood culture bottle that was entered and assigned to a patient; thus, the issue was resolved.Instrument was found to be functional and released to the customer for regular use.This is an unconfirmed complaint, and the root cause was determined to be user workflow error.Dhr review for the instrument (b)(6), is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review revealed no previous complaints for this issue.No parts were replaced as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Complaints for "instrument performance / operation" are under statistical control for the month of (b)(6)2022.The upper control limit was not breached.Quality will continue to monitor the "instrument performance / operation".No new trends have been identified.Review of risk management documentation indicates that the potential risk of the reported failure mode was assessed as severity s1 (user inconvenience) via document baltrmbactecinstraph revision 15 id 13.1.
Event or Problem Description
It was reported that while using the customer bd bactec¿ fx40 instrument the customer assigned the wrong access number to two bottles from different patients.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "correction of patient data and reassignment of blood culture bottle", "the chemist confused the access numbers and wrongly registered the bottles, she inverted the bottles with the patients, she was helped in the correction process and the problem was solved.No impact for the patients".

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14794206
• Report Number: 1119779-2022-00929
• Device Sequence Number: 6108364
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 442296
• Device Catalogue Number: 442296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown