MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) CALIBRATOR KIT MGIT 960; SYSTEM, BLOOD CULTURING

Catalog Number	445871
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the calibrator kit mgit 960 that five (5) false negative results were obtained.There was no health impact or consequences reported.
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.
Additional Manufacturer Narrative
Investigation summary: material 445871 is manufactured by the tubes being filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are packaged into final shipping configurations.The batch history record review for batch 3019836 was satisfactory per internal procedures.Filling and packaging processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 3019836 (17 tubes) were available for inspection.No defects were observed in the retention samples.The retention samples were sent to qc for testing.Batch 3019836 was tested, and the calibrator tubes were reading as satisfactory.Two photos were received to assist with the investigation.One photo was of one calibrator tube of batch 3019836.One photo was of a lab report.No returns were received to assist with the investigation.The qc test consisted of the calibrator tubes being placed in the appropriate position per the instruction manual with satisfactory readings.This complaint cannot be confirmed.Bd will continue to trend complaints for performance issues.
Event or Problem Description
It was reported when using the calibrator kit mgit 960 that five (5) false negative results were obtained.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using calibrator kit mgit 960, there was a false negative result.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated: b5.It was reported while using calibrator kit mgit 960, there was a false negative result.There was no report of patient impact.This supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.
Additional Manufacturer Narrative
The following fields were updated: d2.Medical device type: mdb common device name: system, blood culturing this supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.
Event or Problem Description
It was reported while using calibrator kit mgit 960, there was a false negative result.There was no report of patient impact.

• Brand Name: CALIBRATOR KIT MGIT 960
• 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: 18501593
• Report Number: 1119779-2024-00022
• Device Sequence Number: 8088265
• Product Code: MDB
• UDI-Device Identifier: 00382904458713
• UDI-Public: (01)00382904458713
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• 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,Followup,Followup
• Report Date (Section B): 10/02/2025

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 Expiration Date: 01/11/2025
• Device Catalogue Number: 445871
• Device Lot Number: 3019836
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 11/20/2024; 09/12/2025; 09/30/2025
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 12/02/2024; 09/12/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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