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 Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the bd bbl¿ trypticase¿ soy broth has been found containing biological contamination.The following has been provided by the initial reporter: customer reports 1 tube arrives with contamination in 221716 lot 2026705.Steps taken with customer/troubleshooting: opened a complaint.Customer received 1 tube that was contaminated upon arrival.Tube was discarded.
Additional Manufacturer Narrative
Device evaluated by mfr: 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¿ trypticase¿ soy broth has been found containing biological contamination.The following has been provided by the initial reporter: customer reports 1 tube arrives with contamination in 221716 lot 2026705.Steps taken with customer/troubleshooting: opened a complaint.Customer received 1 tube that was contaminated upon arrival.Tube was discarded.
Additional Manufacturer Narrative
H.6 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 2026705 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 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 or loose caps.Retention samples from batch 2026705 (10 tubes) were available for inspection.No media defects such as turbid/contamination were 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.There was no evidence of loose caps in 10/10 retention samples.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 was 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.Two photos were received to assist with the investigation: the first photo shows an open 100 pack carton with eight tubes in the tube rack.There also is a partial opened carton in the corner of the photo.The caps of seven tubes can be observed.The media cannot be observed in the photo.A loose cap defect cannot be observed from the photo.The last photo shows a closed carton from batch 2026705.No returns were received to assist with the investigation.Based on the evidence provided by the photos this complaint cannot be confirmed for contamination or loose caps.Bd will continue to trend complaints for loose caps and contamination.No additional actions are indicated at this time.Notes: risk management review indicates the potential risks of the defects reported were assessed as severity [01], per baltrmterminalgpaph], rev [02], id [18.0] for [contamination] and severity [s1], per [baltrmterminalgpaph], rev [02], id [4.6] for [cap defects].

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14176718
• Report Number: 1119779-2022-00583
• Device Sequence Number: 4142261
• Product Code: JSG
• UDI-Device Identifier: 30382902217160
• UDI-Public: 30382902217160
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/16/2022

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: 07/26/2023
• Device Model Number: 221716
• Device Catalogue Number: 221716
• Device Lot Number: 2026705
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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