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

Model Number	221283
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	07/06/2021
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 was reported that while using bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) atypical growth was observed by the laboratory personnel.Here was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that growth promotion issues.".
Additional Manufacturer Narrative
This mdr should be considered cancelled.It was determined that this was a quality control issue.Erroneous results during quality control would be suspected and lead to retesting.
Event or Problem Description
It was reported that while using bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) atypical growth was observed by the laboratory personnel.Here was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that growth promotion issues.".

• Brand Name: BD BBL TRYPTICASE SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 12271462
• Report Number: 1119779-2021-01281
• Device Sequence Number: 17264757
• Product Code: JSG
• UDI-Device Identifier: 10382902212833
• UDI-Public: 10382902212833
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/07/2021

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: 09/23/2021
• Device Model Number: 221283
• Device Catalogue Number: 221283
• Device Lot Number: 1152676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1