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

Catalog Number	441385
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 when using the bd bactec¿ fx, instrument top, packaged, there was one blood culture resulting in a false negative.Gram staining detected capnocytophaga canimorsus.No patient impact reported.
Additional Manufacturer Narrative
H.6 investigation summary customer contacted bd support with an inquiry about their bactec fx top 441385 sn ft4420.The customer stated they were running a sample that did not go positive for 2 weeks, however gram staining showed presence of capnocytophaga canimorsus.C.Canimorsus is a slow growing microorganism, and there is evidence that certain strains of capnocytophaga can be inhibited by sodium polyanethole sulfonate, an anticoagulant used in blood sample vials.Additionally, c.Canimorsus is not part of the fx microbial detection test, and therefore this is an unintended use for the fx.Information was requested on blood fill volumes, but no further evidence was reported.No signs of instrument failure have been witnessed.Due to lack of further information, this complaint has been unconfirmed.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 shows no prior issues relating to this complaint failure mode have been opened.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.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.
Event or Problem Description
It was reported that when using the bd bactec¿ fx, instrument top, packaged, there was one blood culture resulting in a false negative.Gram staining detected capnocytophaga canimorsus.No patient impact reported.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT TOP, 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18740933
• Report Number: 1119779-2024-00119
• Device Sequence Number: 7233809
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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 Catalogue Number: 441385
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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