MAUDE Adverse Event Report: BIOMERIEUX, INC. BIOMERIEUX WORKSAFE; BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)

Lot Number 4053578

Device Problem No Flow (2991)

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

Event Date 12/23/2019

Event Type  malfunction  

Event Description

I had two tubes that wouldn't draw.

• Brand Name: BIOMERIEUX WORKSAFE
• Type of Device: BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): BIOMERIEUX, INC.; 100 rodolphe st; durham NC 27712
• MDR Report Key: 10966934
• MDR Text Key: 220168846
• Report Number: 10966934
• Device Sequence Number: 1
• Product Code: OIB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4053578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1