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

Model Number 441385

Device Problem Unintended Movement (3026)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged an issue with the mechanical leveling foot was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the device seems to have shifted a bit to the left.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged an issue with the mechanical leveling foot was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " the device seems to have shifted a bit to the left.".

Manufacturer Narrative

H.6 investigation summary a complaint of "bactec is moving" was received against instrument top bactec fx packaged material number: 441385, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was adjusted the stand feet, thus the issue was resolved.Instrument was found to be functional and released to the customer for regular operation.This is an unconfirmed complaint, and the root cause was unable to be determined.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 / mechanical" are under statistical control for the month of july 2022.The upper control limit was not breached.Quality will continue to monitor the "instrument / mechanical".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 13.2.H3 other text : see h.10.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED
• 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: 15124876
• MDR Text Key: 304716028
• Report Number: 1119779-2022-01036
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K915796A
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441385
• Device Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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