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	08/07/2024
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 while using the bd bactec¿ fx, instrument top, packaged, there was (1) one false negative patient result.The erroneous result was reported to the clinician; however, no health impact or consequences were reported.Confirmatory testing performed included gram stain and culture.
Additional Manufacturer Narrative
Investigation summary: a results failure was reported on a bactec top instrument (p/n 441385, s/n (b)(6)).The customer reported that a bottle became negative after a 5-day protocol.Bd remote services requested the log files and were reviewed, there were no instrumentation issues found during the data analysis that would have caused the false negative.Bd remote services requested further information from the customer, various attempts were made to obtain additional information, but no response was obtained.If further information is provided a new case may be re-opened.This is an unconfirmed failure of a bd product.Physical samples were not received by quality for investigation however, log files were received and reviewed.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 for this instrument was completed and revealed one previous case (b)(4) related to results.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
Event or Problem Description
It was reported while using the bd bactec¿ fx, instrument top, packaged, there was (1) one false negative patient result.The erroneous result was reported to the clinician; however, no health impact or consequences were reported.Confirmatory testing performed included gram stain and culture.

• 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: 20135882
• Report Number: 1119779-2024-00657
• Device Sequence Number: 17963776
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: (01)00382904413859(11)140327
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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