MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; PACK, HOT OR COLD, DISPOSABLE

Model Number 11450-040

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

The nurse was activating the hot pack by squeezing it to "pop" and mix the chemicals, but the hot pack opened and the chemicals spilled all over their arms.The nurse quickly washed their arms and there was no injury.

• Brand Name: CARDINAL HEALTH
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10199822
• MDR Text Key: 196583948
• Report Number: 10199822
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: (01)10885380167188
• 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: 06/25/2020

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 Model Number: 11450-040
• Device Catalogue Number: 11450-040B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1