MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY UNIVERSAL VIRAL TRANSPORT FLOCK FLEX MINI; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number	220526
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The red cap on the tubes for the universal viral transport for viruses, chlamydiae, mycoplasmas, and ureaplasmas (covid/flu swab) was stuck for all specimens.

• Brand Name: UNIVERSAL VIRAL TRANSPORT FLOCK FLEX MINI
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 13190822
• Report Number: 13190822
• Device Sequence Number: 19934647
• Product Code: JSM
• UDI-Device Identifier: 30382902205266
• UDI-Public: (01)30382902205266
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/16/2021
• Report Date (Section F): 11/16/2021

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
• Device Model Number: 220526
• Device Catalogue Number: 220526
• Device Lot Number: 210796100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/16/2021