MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	297292
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	04/01/2022
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, enriched with vitamin k1 and hemin has been found experiencing seven occurrences of containing biological contamination.The following has been provided by the initial reporter: it was reported that there is mold inside tubes after inoculation.
Event or Problem Description
It has been reported that the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin has been found experiencing seven occurrences of containing biological contamination.The following has been provided by the initial reporter: it was reported that there is mold inside tubes after inoculation.
Additional Manufacturer Narrative
H.6 investigation summary: material 297292 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 1222908 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torqueing, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.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 1222908 (10 tubes) were available for inspection.No media, or tube defects were observed in 10/10 retention samples.No signs of turbidity or contamination observed in 10/10 retention samples.For investigation, one retention tube was incubated at 33 to 37 degrees celsius, and one retention tube was incubated at 20 to 25 degrees celsius.There were no signs of microbial growth after seven days of incubation from 2/2 retention samples.One photo was received to assist with the investigation: the photo shows one tube from batch 1222908.The media does appear to be contaminated.There is tape around the cap and the tube has tape around the middle of the tube.No returns were received to assist with the investigation.This complaint can be confirmed based on the evidence provided by the photo.No actions are indicated at this time and bd will continue to trend complaints for contamination.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• 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: 14189959
• Report Number: 1119779-2022-00594
• Device Sequence Number: 19904706
• Product Code: JSG
• UDI-Device Identifier: 30382902972922
• UDI-Public: 30382902972922
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K803023
• 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): 09/16/2022

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: 08/06/2022
• Device Model Number: 297292
• Device Catalogue Number: 297292
• Device Lot Number: 1222908
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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