MAUDE Adverse Event Report: CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER; HOT DISPOSABLE PACK

Catalog Number V11460-010

Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

These infant heel warmers are very difficult to use.It takes an extreme amount of pressure to break them up and then sometimes they break open, which is what happened to this device.Sometimes we are actually unable to break up the device to activate the heat element, so we move on to another one.There are numerous individual devices that have been defective or unable to break or opened upon breaking.We have a box in our neonatal intensive care unit (nicu) that we are collecting those that have malfunctioned.I grabbed one out of that box to initiate this report.I am not certain what is wrong with the one that i have.

• Brand Name: NOVAPLUS INFANT HEEL WARMER
• Type of Device: HOT DISPOSABLE PACK
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 6666548
• MDR Text Key: 78378795
• Report Number: 6666548
• 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: 06/22/2017

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: Nurse
• Device Catalogue Number: V11460-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• 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
• Treatment: NOT APPLICABLE.