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

Model Number	246001
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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 while using bd phoenix¿; id broth the broth was discovered to be contaminated.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: this complaint is for phoenix id broth (246001) batch 0106932 that contained contaminated tubes.Samples were originally sent back from the customer, however they were sent to the incorrect site.During transfer of the samples from the incorrect location to sparks, the samples were misplaced and unable to be located.In addition to the samples, 2 photos were also provided by the customer which showed foreign matter in the tube.Additionally, a retention box ((b)(4)) from this complaint batch was visually inspected for contaminated tubes.Zero out of the 100 tubes inspected were contaminated.Based on the photos provided, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on this complaint batch.A review of complaints was performed and there were no additional complaints filed for this batch.Complaint trending was performed and no trends were identified associated with the complaint batch or defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using bd phoenix¿; id broth the broth was discovered to be contaminated.There was no report of patient impact.

• Brand Name: BD PHOENIX; ID BROTH
• 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: 11505545
• Report Number: 1119779-2021-00498
• Device Sequence Number: 19547182
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 04/14/2021
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 0106932
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1