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

Model Number	441386
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
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 while using bd bactec¿ fx, instrument bottom, packaged vial broke accidently while training was on-going, and blood got spilled over the rack.The following information was provided by the initial reporter vial broke accidently while training was on-going, and blood got spilled over the rack.
Additional Manufacturer Narrative
Investigation summary customer contacted bd support to help them with disinfection of their bactec fx bottom 441386 sn (b)(6) due to a broken bottle.Bd field service engineer went onsite and disinfected the instrument.This is an unconfirmed complaint of a bd instrument.Device history review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service review showed no prior failures related to broken bottles.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 is due to a broken bottle.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Complaints for instrument/mechanical are under statistical control for the month of september 2022.The upper control limit was not breached, and no trends have been identified.Review of risk management documentation indicates the potential risk of the reported failure mode was assessed as severity s1 if no pathogen exposure via document baltrmbactecinstraph rev 15, row id 13.14.
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument bottom, packaged vial broke accidently while training was on-going, and blood got spilled over the rack.The following information was provided by the initial reporter vial broke accidently while training was on-going, and blood got spilled over the rack.

• 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: 15503697
• Report Number: 1119779-2022-01242
• Device Sequence Number: 12724724
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/01/2022

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: 09/20/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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