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

Catalog Number	448012
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
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 while using bd phoenix¿ ap id broth biological contamination was observed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they started seeing purity plates with pseudomonas aeruginosa.Customer did decontamination and cultured the bag.The bag grew p.Aeruginosa.Customer did additional testing and found the lot to be contaminated.This event occurred 8 times.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is for contaminated phoenix ap id broth (448012) batch 2060448.Customer started seeing purity plates with pseudomonas aeruginosa.Customer did (ap) decontamination and cultured the bag (ref pr #(b)(4)).The bag grew p.Aeruginosa.Customer did additional testing and found the lot to be contaminated.The customer did not provide photos for the investigation.The customer returned one opened and four opened bags of ap id broth batch #2060448.The samples were manually visually inspected and no signs of contamination (cloudy, turbid, etc.) were observed.As part of the investigation, samples from two retention phoenix ap id broth bags of the complaint batch were streaked onto tsa blood agar plates and columbia/can with 5% blood agar plates and placed into the incubator overnight to observe for growth on the plates.No growth was noted on either of the tsa plates or columbia plates for either sample of the phoenix ap id broth.Based on the investigation performed, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed no additional complaints on the complaint batch.Complaint trending was performed, and no trends were identified associated with this 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¿ ap id broth biological contamination was observed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they started seeing purity plates with pseudomonas aeruginosa.Customer did decontamination and cultured the bag.The bag grew p.Aeruginosa.Customer did additional testing and found the lot to be contaminated.This event occurred 8 times.

• Brand Name: BD PHOENIX¿ AP 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
• 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: 15180012
• Report Number: 1119779-2022-01081
• Device Sequence Number: 6222546
• Product Code: JSG
• UDI-Device Identifier: 30382904480128
• UDI-Public: 0130382904480128
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 448012
• Device Lot Number: 2060448
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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