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

Catalog Number	445871
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after using the bd bactec mgit 960 calibrator kit, an unspecified number of tubes tested false positive.The customer noted no bacteria or mycobacteria in the false positive tubes.There was no health impact or consequences reported.
Additional Manufacturer Narrative
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 4044267 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 4044267 (17 tubes) were available for inspection.No defects were observed in the retention samples.The retention samples were sent to qc for testing.Batch 4044267 was tested, and the calibrator tubes were reading as satisfactory.There were no photos or returns 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.
Event or Problem Description
It was reported after using the bd bactec mgit 960 calibrator kit, an unspecified number of tubes tested false positive.The customer noted no bacteria or mycobacteria in the false positive tubes.There was no health impact or consequences reported.

• Brand Name: BD BACTEC MGIT 960 CALIBRATOR KIT
• 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: 19651104
• Report Number: 1119779-2024-00534
• Device Sequence Number: 12643961
• Product Code: MDB
• UDI-Device Identifier: 00382904458713
• UDI-Public: (01)00382904458713(11)240213(17)260211(10)4044267
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 02/11/2026
• Device Catalogue Number: 445871
• Device Lot Number: 4044267
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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