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

Model Number	441386
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bactec¿ fx, instrument bottom, packaged right front foot of the fx is bent at a 33 degrees.No injuries were reported.The following information was provided by the initial reporter: right front foot of the fx is bent at a 33 degrees and will not move up or down.Instrument is running currently with no noise.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of "bent foot on fx may cause safety issue" was received against instrument bottom bactec fx packaged material number: 441386, serial number: (b)(6).A bd field service engineer (fse) was dispatched.The fse was replaced the blower coupling and set of feet bfx spare, thus the issue was resolved.Instrument was found to be functional and released to customer for regular operation.This complaint is a confirmed failure of the bd product based on the service investigation.The root cause was unable to be determined as no materials were received for investigation.Device history record 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.Samples were not received by quality for investigation and thus, returned material investigation could not occur.No new risks, or hazards were identified as a result of the complaint.
Event or Problem Description
It was reported that bd bactec¿ fx, instrument bottom, packaged right front foot of the fx is bent at a 33 degrees.No injuries were reported.The following information was provided by the initial reporter: right front foot of the fx is bent at a 33 degrees and will not move up or down.Instrument is running currently with no noise.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16521037
• Report Number: 1119779-2023-00267
• Device Sequence Number: 6515351
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 441386
• Device Catalogue Number: 441386
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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