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	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ id broth, 4 cases of biological contamination and physical defects were observed by the laboratory personnel.There 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: the id broth volume is less than standard volume and contaminant occur on some tubes.
Additional Manufacturer Narrative
Investigation summary: this complaint is for low volume and contaminated phoenix id broth tubes (246001) batch 1140913.The customer did return a photo for investigation.The photo showed multiple tubes with low volume broth and a debris almost dust/dirt like material on the outside of the tubes.Based on the photo provided, this complaint is confirmed for both low volume and contamination.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one additional complaint on the complaint batch.A complaint trend was identified for this defect.Based on the severity and rate, a corrective and preventive action (capa) investigation was not initiated.Rather, this defect will be evaluated for further continuous improvement opportunities.Bd id/ast plant quality will continue to closely monitor trends for this defect, including changes in severity and rate.Please continue to communicate any additional concerns.It is to be noted a trend in low fill/empty tube complaints has been observed for phoenix id broth (246001).As part of the investigation for low fill, the tube and cap were analyzed by bd¿s packaging engineering team.Analysis of the helical cap concluded that there is an internal thread measurement which is slightly out of tolerance.This condition leads to non-uniform liner compression when the cap is affixed to the tube.Bd is actively working with the cap vendor to determine root cause and corrective actions.

• 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: 12693628
• Report Number: 1119779-2021-01710
• Device Sequence Number: 17184994
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 05/12/2022
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 1140913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1