MAUDE Adverse Event Report: CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	V11460-010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Event or Problem Description
Nurses described that when they squeeze to activate the product, the pouch would rupture, and the contents would spill out.Customer reported that during activation, the infant heel warmer ruptured onto nurse¿s 2nd and 3rd digit on left hand causing erythema and numbness.Hands were washed with soap and water.No further follow up care was required.Nurse reported currently the affected area has occasional tingling after 2 weeks.Actual event date is unknown by customer.
Additional Manufacturer Narrative
The device history review was completed on the reported lot number v2a051.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The reported event could not be confirmed, as no samples were returned by the customer for evaluation.Without the sample a root cause could not be determined.We will continue to monitor complaint trends.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood dr.; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14458849
• Report Number: 1423537-2022-00766
• Device Sequence Number: 11911210
• Product Code: MPO
• UDI-Device Identifier: 10885380057588
• UDI-Public: 10885380057588
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V2A051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female