MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221200
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
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 has been reported that the bd bbl¿ thioglycollate medium without indicator has been found containing biological contamination.The following has been provided by the initial reporter: customer problem: customer reports contamination for cat 221200 lot 1209940.
Additional Manufacturer Narrative
H.6 investigation summary: material 221200 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 1209940 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving processes were within specifications.Qc inspection and testing was satisfactory at time of release.Direct staining techniques are not part of qc release testing for this product.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 1209940 (10 tubes) were available for inspection.No media defects such as turbid/contamination was observed in 10/10 retention samples.All retentions tubes had the expected appearance for material 221716 of light to medium light yellow, trace hazy to clear as specified in the certificate of analysis.For further investigation, two retention sample tubes were tested for contamination.One retention tube was incubated in the 20-25 degree c incubator, and one retention tube were placed in the 33-37 degree c incubator.At 7 days incubation, there were no signs of growth or turbidity from 2/2 incubated retention tubes.A gram stained was performed and no viable organisms were found.No photos were received to assist with the investigation.Returns were received to assist with the investigation.A shipping box with sixty-six tubes from batch 1209940 was received.There was no evidence of contamination or turbid media from visual inspection of 66/66 returned tubes.The media had the expected color and clarity of light to medium light yellow, trace hazy to clear as specified in the certificate of analysis.For further investigation, the return tubes 66/66 were incubated.Thirty-three tubes were placed in the 33-37 degree c incubator, and thirty-two tubes were placed in the 20-25-degree celsius incubator.At 7 days incubation, there were no signs of growth or turbidity in 65/65 returned tubes.A gram stained was performed on one nonincubated return tube and no viable organisms were found.This complaint can be confirmed for non-viables.Bd will continue to trend complaints for appearance/non-viable organisms.Caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides, and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.
Event or Problem Description
It has been reported that the bd bbl¿ thioglycollate medium without indicator has been found containing biological contamination.The following has been provided by the initial reporter: customer problem: customer reports contamination for cat 221200, lot 1209940.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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 ; 8015296192
• MDR Report Key: 14292140
• Report Number: 1119779-2022-00658
• Device Sequence Number: 20215004
• Product Code: JSG
• UDI-Device Identifier: 30382902212004
• UDI-Public: 30382902212004
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 08/02/2022
• Device Model Number: 221200
• Device Catalogue Number: 221200
• Device Lot Number: 1209940
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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