MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP); SYSTEM, BLOOD CULTURING

Model Number	245111
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (25/sp) that there was false negatives.The following information was provided by the initial reporter: customer reports a possible false negative incident with tubes 245111 with lot#: 2272719.
Additional Manufacturer Narrative
H.6 investigation summary: material 245111 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 2272719 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.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 2272719 (100 tubes) were available for inspection.No defects were observed in (b)(4) tubes from visual inspection.For further investigation, retentions were performance tested for growth and antibiotic susceptibility.All performance testing was satisfactory for growth and antibiotic susceptibility per qc standard operating procedures.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.No complaint trends for this defect has been identified for this product ;no actions are indicated at this time.
Event or Problem Description
It was reported that while using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (25/sp) that there was fasle neagtives.The following information was provided by the initial reporter: customer reports a possible false negative incident with tubes 245111 with lot#: 2272719.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP)
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16475809
• Report Number: 1119779-2023-00212
• Device Sequence Number: 15318216
• Product Code: MDB
• UDI-Device Identifier: 30382902451113
• UDI-Public: 30382902451113
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K954932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 09/22/2023
• Device Model Number: 245111
• Device Catalogue Number: 245111
• Device Lot Number: 2272719
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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