MAUDE Adverse Event Report: CARDINAL HEALTH; INFANT HEEL WARMER

Model Number 11470-01-01

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 09/18/2017

Event Type  malfunction  

Event Description

Heel warmer solution leaked out of package after activation.

• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 6939991
• MDR Text Key: 88951953
• Report Number: 6939991
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

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: No Information
• Device Expiration Date: 12/01/2019
• Device Model Number: 11470-01-01
• Device Catalogue Number: 11470-01-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1