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

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problem Erythema (1840)

Event Date 01/01/1980

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 292204093
• Report Number: 1423537-2022-00766
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female