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

Model Number 442296

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

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 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".

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 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
• Type of Device: 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
• MDR Text Key: 303143443
• Report Number: 1119779-2022-00929
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 442296
• Device Catalogue Number: 442296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1