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 (1120)

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

Event Date 03/02/2022

Event Type  malfunction  

Event Description

It was reported that the bd phoenix¿ ast broth was contaminated.There was no report of adverse user or patient impact.The following information was provided by the initial reporter, translated from (b)(6): "the broth was contaminated.".

Manufacturer Narrative

Investigation summary: 2 defect samples were returned.Bdj confirmed that 1 of the broth was muddy and another one was empty.The customer provided photos for investigation as well.The photos provided showed one tube with low volume and one tube with what looks like biological contamination.This complaint is 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 for this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

• 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: 13956717
• MDR Text Key: 292829001
• Report Number: 1119779-2022-00478
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/04/2022
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 1313833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1