MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BACTEC 9120 BLOOD CULTURE; SYSTEM, BLOOD CULTURING

Catalog Number	445570
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
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 that when using the bactec 9120 blood culture, there was one false negative result.No patient impact reported.
Additional Manufacturer Narrative
Investigation summary: the complaint was created for bactec 9120 blood culture system (p/n 445570, s/n (b)(6)).The customer reported they found the false negatives results during sub-culturing.After that, the instrument was working without any error message nor alerts.Therefore, the complaint is unconfirmed.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.Device history record 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 no previous complaints related to results issues.Review of risk management files confirm 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 bactec 9120 blood culture, there was one false negative result.No patient impact reported.

• Brand Name: BACTEC 9120 BLOOD CULTURE
• 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: 19888497
• Report Number: 1119779-2024-00571
• Device Sequence Number: 7796985
• Product Code: MDB
• UDI-Device Identifier: 00382904455705
• UDI-Public: (01)00382904455705(11)140327
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K922475
• 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): 10/02/2024

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: 445570
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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