MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CRD; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number 65651-515

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/27/2021

Event Type  malfunction  

Event Description

Unhooked the canister suction from the wall suction( after they turned the suction completely off) and poop spewed out of the top causing a fluid eruption that went on staff member clothes, hair and covered their ppe.This has occurred 3 other times on separate occasions.

• Brand Name: CRD
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 13541455
• MDR Text Key: 285680258
• Report Number: 13541455
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2022

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: Health Professional
• Device Catalogue Number: 65651-515
• 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: 01/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1