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

Model Number	221815
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the bd bbl¿ trypticase¿ soy broth has been found experiencing performance issues.The following has been provided by the initial reporter: it was reported by the customer that they are getting inconsistent growth, color and ph when adding agar to their 221815 prepared tubes to make tsa plates.
Additional Manufacturer Narrative
H.6 investigation summary: material 221815 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.Unknown batch 008275 batch number 008275 was provided for investigation.The batch history record review for batch 008275 yielded no result.There is no production record of material 221815 batch number 008275.No return samples were received to assist with the investigation.No photos were received to assist with this investigation.Retention samples cannot be evaluated without a specific batch number.Trending was done on the appropriate databases for trypticase soy broth 2ml (material 221815) and no quality notification trends have been identified for this material for performances or appearance in the last 12 months.The complaint history was reviewed for material 221815 and there are no trends for performances or appearance in the last 12 months.This complaint cannot be confirmed based on material trending.No actions are indicated at this time and bd will continue to trend complaints for this issue.Unknown batch 206466 batch number 206466 was provided for investigation.The batch history record review for batch 206466 yielded no result.There is no production record of material 206466 batch number 206466.No return samples were received to assist with the investigation.No photos were received for to assist with the investigation.Retention samples cannot be evaluated without a specific batch number.Trending was done on the appropriate databases for trypticase soy broth 2ml (material 221815) and no quality notification trends have been identified for this material for performances or appearance in the last 12 months.The complaint history was reviewed for material 221815 and there are no trends for performances or appearance in the last 12 months.This complaint cannot be confirmed based on material trending.No actions are indicated at this time and bd will continue to trend complaints for this issue.It is to be noted that bd does sell dcm products and agar products, however this liquid media product is to be used as is per product claims.The addition of any material to this media is not within product claims per the package insert.Notes: risk management review indicates the potential risks of the defects reported were assessed as severity [s2], per [baltrmterminalgpaph], rev [02], id [2.21] for [atypical growth] and severity [s1], per [baltrmterminalgpaph], rev [02], id [4.0] for [color variation] and severity [s3], per [baltrmterminalgpaph], rev [02], id [2.31] for [ph].
Event or Problem Description
It has been reported that the bd bbl¿ trypticase¿ soy broth has been found experiencing performance issues.The following has been provided by the initial reporter: it was reported by the customer that they are getting inconsistent growth, color and ph when adding agar to their 221815 prepared tubes to make tsa plates.

• 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: 14628477
• Report Number: 1119779-2022-00829
• Device Sequence Number: 6113720
• Product Code: JSG
• UDI-Device Identifier: 30382902218150
• UDI-Public: 30382902218150
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Model Number: 221815
• Device Catalogue Number: 221815
• Device Lot Number: UNKNOWN
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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