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	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bactec¿ fx, instrument bottom, packaged had the left foot broken.The rivet which holds the feet stripped off the base of the strut.No patient impact was reported.The following information was provided by the initial reporter: while charlie lau (sr.Fse) was on-site for (ref: wo-02648164 and wo-02648195), fse noticed the left foot of the bottom bactec fx broken; the rivet which holds the feet stripped off the base of the strut.
Additional Manufacturer Narrative
Medical device expiration date: na.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 had the left foot broken.The rivet which holds the feet stripped off the base of the strut.No patient impact was reported.The following information was provided by the initial reporter: while charlie lau (sr.Fse) was on-site for (ref: (b)(4)), fse noticed the left foot of the bottom bactec fx broken; the rivet which holds the feet stripped off the base of the strut.
Additional Manufacturer Narrative
H.6 investigation summary: bd field service engineer went onsite to investigate and found damage to the foot.The leveling foot was replaced with a new component and the instrument was returned to use.Given the age of the instrument and the unknown nature of the damage, bd cannot confirm this complaint as a failure of an instrument.Dhr review 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 showed one prior complaint for a broken right leveling foot.Bd suggested new parts for replacement, however no purchase order was ever placed by the customer.The case was subsequently closed.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.If samples are received at a later date, the complaint may be reopened.The root cause of the damage is unknown.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15580586
• Report Number: 1119779-2022-01290
• Device Sequence Number: 17688063
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/15/2022

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: 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: 10/03/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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