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

Model Number 246004

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using bd phoenix¿ ast indicator solution atypical growth was observed by the laboratory personnel in 10 samples.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00297 was sent in error.It was found that there was no result given by the instrument.

Event Description

It was reported that while using bd phoenix¿ ast indicator solution atypical growth was observed by the laboratory personnel in 10 samples.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD PHOENIX AST INDICATOR SOLUTION
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11319156
• MDR Text Key: 242064702
• Report Number: 1119779-2021-00297
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• Combination Product (y/n): N
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 0066335
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1