MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Catalog Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problems Eye Injury (1845); Eye Injury (1845); Chemical Exposure (2570)

Event Date 11/29/2016

Event Type  malfunction  

Event Description

Phlebotomist squeezed the warming packet to activate the chemicals (per instructions on the packet) and it exploded.She got some in her eye and on her clothes.She was seen in employee health and flushed out her eye.She was told contents are non-toxic and food grade.Infant was not harmed since the packet had not been applied to the heel at the time of the event.

• Brand Name: CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 west highway 24; moberly MO 65270
• MDR Report Key: 6144485
• MDR Text Key: 241269188
• Report Number: 6144485
• 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: Patient
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

2 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 Catalogue Number: V11460-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2016
• 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