MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221716
Medical Device Problem Codes	Contamination (1120); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
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 after bd bbl¿ trypticase¿ soy broth were contaminated.Customer inoculated 5 tubes and obtained false positive result for gnr.Customer also tested 3 un-inoculated tubes and they also had false positive for gnr.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that customer reporting contamination with product 221716 lot 0174108 5 from patient samples and 3 customer tested from uninoculated tubes.8 total when was the contamination observed? before or after inoculation/incubation? before or after opening sleeves? patient samples tubes were inoculated and incubated and the organism was found on gram stain after that.Customer also did gram stain on uninoculated tubes and found organism.Upon visual inspection of the contaminated media was the contamination: bacteria or fungi? bacterial.
Additional Manufacturer Narrative
H6 investigation summary : material 221716 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 0174108 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and torquing 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 for contamination.Retention samples from batch 0174108 (10 tubes) were available for inspection.No cap, tube or media defects were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of light to medium light yellow, trace hazy to clear.For further investigation, two retention samples from batch 0174108 were tested for growth.One retention tube was incubated in the 20¿25-degree celsius incubator.One retention tube was incubated in the 33¿37-degree celsius incubator.No microbial growth was no signs of microbial growth within a seven-day incubation period.A gram stain was performed.The gram stain revealed gram variable rods.No photos were received to assist with the investigation.Returns were received for the investigation.Three tubes individually wrapped in tissue paper and placed in plastic bags from batch 0174108 were received a shipping box.The tubes were received in good condition with no visible signs of contamination from visual inspection.For further investigation, return samples from batch 0174108 were tested for growth.One return tube was incubated in the 20¿25-degree celsius incubator.The one return tube was placed in the 33¿37-degree celsius incubator.One return tube was plated onto two tsa 5% sheep blood media one plate was incubated at 20-25-degrees celsius and one plate was placed into 33-37-degrees celsius.At 7 days incubation, there were no signs of growth or turbidity in 2/2 returned tubes and no microbial growth was observed on either plate.A gram stain was performed on one of the incubated return tubes.The gram stain revealed gram-negative rods.The complaint can be confirmed for non-viables based on return sample testing.A trend has not been identified, therefore, no actions are planned at this time.Bd will continue to trend complaints for non-viables.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.Bd will continue to trend complaints for contamination and non-viables.This complaint can be confirmed for non-viables.See h10.
Event or Problem Description
It was reported that after bd bbl¿ trypticase¿ soy broth were contaminated.Customer inoculated 5 tubes and obtained false positive result for gnr.Customer also tested 3 un-inoculated tubes and they also had false positive for gnr.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that customer reporting contamination with product 221716 lot 0174108 5 from patient samples and 3 customer tested from uninoculated tubes.8 total *when was the contamination observed? before or after inoculation/incubation? before or after opening sleeves? patient samples tubes were inoculated and incubated and the organism was found on gram stain after that.Customer also did gram stain on uninoculated tubes and found organism.Upon visual inspection of the contaminated media was the contamination: -bacteria or fungi? bacterial.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12911535
• Report Number: 1119779-2021-01897
• Device Sequence Number: 5085211
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/30/2022

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: 12/22/2021
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 0174108
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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