MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM; SEE H.10

Model Number	221196
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd bbl¿ fluid thioglycollate medium that there was contamination growth on the plate.The following information was provided by the initial reporter: customer reports that they had growth in a negative control in (b)(4).
Additional Manufacturer Narrative
Common device name: culture media, non-selective and non-differential.Initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: "material 221196 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The media is dispensed into bottles; caps are applied manually then torqued by machine per a standard operating procedure (sop).The bottles are then labeled and terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, bottles are packaged into final shipping configurations.The batch history record review for batch: 2312524 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing was satisfactory at time of release.The complaint history was reviewed, and one other complaint has been taken on this batch.Retention samples from batch: 2312524 (10 tubes) were available for inspection.The certificate of analysis states the media appearance should be light yellow with no more than 1/3 of fill showing rose pink at the top of the medium and medium is clear yellow when heated.All 10/10 retention samples maintained the color/appearance within the specifications described by the certificate of analysis.For further investigation two retention tubes were incubated.One tube was placed into 20-25-degree celsius, and one retention tube was placed into 33-37-degrees celsius.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated retention tubes.One video was received to assist with the investigation: the video shows two tubes from batch: 2312524.The first tube held up in the video there does appear to be possibly growth or sedimentation in the tube.The second tube the color and clarity of the media appears light yellow with no more than 1/3 of fill showing rose pink at the top of the medium as described in the certificate of analysis (when the media is heated it turns a clear yellow).".
Event or Problem Description
It was reported that while using the bd bbl¿ fluid thioglycollate medium that there was contamination growth on the plate.The following information was provided by the initial reporter: customer reports that they had growth in a negative control in 221196.

• Brand Name: BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM
• Common Device Name: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16575530
• Report Number: 1119779-2023-00305
• Device Sequence Number: 7150269
• Product Code: JSG
• UDI-Device Identifier: 30382902211960
• UDI-Public: 30382902211960
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 05/31/2023

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: 05/25/2023
• Device Model Number: 221196
• Device Catalogue Number: 221196
• Device Lot Number: 2312524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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