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

Catalog Number V11460-010

Device Problems Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Material Rupture (1546)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

The novaplus infant heel warmer packets (teal/white packaging) is "exploding" when activated.When squeezed to activate the contents, the seal on the packaging opens up and the contents spray across the area.One staff has made contact with her skin and caused some irritation.Defective item did not reach the baby.Temperature control.

• Brand Name: NOVAPLUS INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 16630204
• MDR Text Key: 312264700
• Report Number: MW5116039
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V11460-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic