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 (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
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 2241644 was satisfactory per internal procedures.Formulation, filling, torquing, 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 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 complaint has been taken on this batch.Retention samples from batch 2241644 (10 tubes) were available for inspection.The retention samples showed no media defects in 10/10 tubes from visual inspection.The color and clarity was light to medium light yellow, trace hazy to clear, as described in the certificate of analysis.For investigation, two uninoculated retention tubes were incubated.One tube was placed in the 33-to-37-degree celsius incubator and one tube was placed in the 20-to-25-degree celsius incubator.No microbial growth or turbidity of the media was seen in 2/2 incubated retention tubes at seven days incubation.There was no change in the media color and clarity in 2/2 incubated retention tubes.No product photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed based on retention sample investigation.Contamination was not observed in the retention samples.Bd will continue to trend complaints for contamination/appearance defects.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.Additionally, this product is not labeled sterile.As stated in our package insert, "do not use medium if it shows evidence of microbial contamination, discoloration, drying or other signs of deterioration".H3 : see h.10.
Event or Problem Description
It was reported that bd bbl¿ thioglycollate medium without indicator there were 3 occurrences of positive gram stain, but no growth in media.The following information was provided by the initial reporter: positive gram stain, but no growth in media.These were showing up on some gram stains we were doing on tissue cultures that we used thio broth to grind up for culture.Because we saw the gram-negative rods in the gram stains on a few tissue cultures, but not growing on any media, we questioned if there was some kind of contaminant.We tested the tissue grinders, thio broth and slides.The thio broth was what had the contaminant of the non-viable gram-negative rods in them.One was reported on a preliminary gram stain report.And it was promptly corrected/called afterwards.The others were not reported in the respective patients emr.They were about 6 cultures belonging to 3 different patients.Lot #2241644.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16939405
• Report Number: 1119779-2023-00562
• Device Sequence Number: 7451393
• Product Code: JSG
• UDI-Device Identifier: 30382902212004
• UDI-Public: 30382902212004
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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: 08/19/2023
• Device Model Number: 221200
• Device Catalogue Number: 221200
• Device Lot Number: 2241644
• 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: 04/20/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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