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

Model Number	246004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
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.(b)(4).
Event or Problem Description
It was reported that while using bd phoenix¿ ast indicator solution a broken bottle was observed by the laboratory personnel.In the event of a broken or leaking bottle, there is potential for injury and exposure to eyes, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials.There was no report of patient impact.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00248 was sent in error.There was no exposure to blood as sample leaked into sensor compartment in bottle, therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using bd phoenix¿ ast indicator solution a broken bottle was observed by the laboratory personnel.In the event of a broken or leaking bottle, there is potential for injury and exposure to eyes, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials.There was no report of patient impact.

• Brand Name: BD PHOENIX AST INDICATOR SOLUTION
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11282342
• Report Number: 1119779-2021-00248
• Device Sequence Number: 3482465
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 03/31/2021
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 0066297
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1