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

Model Number	V11460-010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) activated the heel warmer as usual and placed it on infant¿s heel.Nurse began assessment and mid assessment (~2 minutes), the heel warmer popped/exploded and the contents splatted against inside of isolette- on blankets, wall of isolette and out of porthole door onto floor.Seam popped open, contents of package went on infant¿s bilateral lower legs, below the knees, and bedding changed.Heel warmer promptly removed and infant cleaned of contents.

• Brand Name: NOVAPLUS INFANT HEEL WARMER
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19574436
• Report Number: 19574436
• Device Sequence Number: 19819344
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: (01)10192253061468
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/14/2024
• Report Date (Section F): 02/14/2024

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 Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Date Report Sent to FDA: 02/14/2024