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	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd bactec¿ fx, instrument top, packaged there was a false negative on drawer b station k6.Results were not reported out.No patient impact.Report 1 of 2.
Additional Manufacturer Narrative
Investigation summary customer contacted bd support regarding their bactec fx top 441385 sn (b)(6) alleging false results on station k6.The customer stated a suspension was inoculated into 2 different ped bottles and was inserted into 2 stations, at drawer b station k6 and k7, but only k6 called out as no growth.When subcultured, organisms from sample k6 grew.Bd service reached out with a service quote, but no communication was ever received back from the customer.The complaint has been closed due to lack of communication.The root cause is unable to be determined and the complaint is 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 one prior complaint opened for false positive results, which was root caused to coupler failure.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 while using the bd bactec¿ fx, instrument top, packaged there was a false negative on drawer b station k6.Results were not reported out.No patient impact.Report 1 of 2.

• 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: 19006558
• Report Number: 1119779-2024-00236
• Device Sequence Number: 9373153
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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