MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST BROTH; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number 246003

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

Describe event: "it was reported when using bd phoenix¿ ast broth, biological contamination was encountered.This event occurred one times.The following information was provided by the initial reporter: defects.Biological contamination identified by technical service.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Describe event: "it was reported when using bd phoenix¿ ast broth, biological contamination was encountered.This event occurred one times.The following information was provided by the initial reporter: defects biological contamination identified by technical service.

Manufacturer Narrative

Investigation summary: this complaint is confirmed.This complaint is for foreign material seen within in a tube of phoenix ast broth (246003) batch number 2033321.The customer did provide photos for investigation, but no product returns.The photos illustrated white foreign material inside of the broth tube.Based off the photos, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and revealed no additional complaints on the complaint batch.Complaint trending was performed and no trends were identified associated with this defect.A bd id/ast plant quality will continue to monitor for trends associated with this defect.Per baltrmphxidastaph rev 10 version h, id 15.0, a defective product obvious to user has a severity assessment of s1.Per baltms0184 ver k a complaint with a severity ranking of s1 or s2 may require investigational testing, including retain sample analysis.However, the customer returned photos which were used for the investigation; therefore, a review of retention samples is not required.

• Brand Name: BD PHOENIX¿ AST BROTH
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: 15171809
• MDR Text Key: 304818493
• Report Number: 1119779-2022-01071
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/28/2023
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 2033321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1