MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review (dhr) was completed on the reported lot v2a051.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.A sample was not returned for investigation, therefore a root cause could not be determined.We will continue to monitor trends for this product.
Event or Problem Description
Customer reported that when activating the infant heel warmer as instructed, it burst and contents went across the room hitting staff member¿s jacket.There was no skin exposure or adverse event.Event date is unknown.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr; waukegan, IL 60085 ; 8878474151
• MDR Report Key: 14598381
• Report Number: 1423537-2022-00776
• Device Sequence Number: 5492125
• 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): 06/03/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/03/2022
• 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: Unknown