MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	11460-010T
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review was completed on the reported lot number v2b263.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The actual complaint sample was returned for evaluation already activated.The root cause was determined to be a cut pouch.It is very unlikely this pouch was cut before leaving the manufacturing site; the product was not reworked, and employees are not to open shippers using sharp instruments.Further, shipper artwork instructs ¿do not use knife to open.¿ therefore, the root cause is likely due to the customer failing to follow packaging directions.We will continue to monitor trends for this product.
Event or Problem Description
When the nurse went to activate the package it exploded into her hand.She was not hurt, she quickly washed it off she stated it was a slight burning sensation but nothing else.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15803869
• Report Number: 1423537-2022-00857
• Device Sequence Number: 14828163
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V2B263 D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female