MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS INFANT HEEL WARMER 4X4IN; PACK, HOT OR COLD, DISPOSABLE

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 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.We received one sample for investigation on (b)(6) 2022.The sample was already activated.The root cause was determined to be a void in the side seal.This was determined to be due to inadequate preventative maintenance on the pouch machine.As a correction, the manufacturing site has implemented a centerline sheet for the pouch machine which ensures the machine maintenance is being preformed at a proper interval.Cardinal health will continue to monitor complaint trends.
Event or Problem Description
Customer report that when activating the infant heel warmer as instructed, it burst, and contents went across the room hitting staff member.The staff member was wearing gloves, therefore no skin exposure or adverse event to staff or patient.No demographic or other information provided.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 4X4IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 14681664
• Report Number: 1423537-2022-00790
• Device Sequence Number: 20218487
• Product Code: IMD
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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 Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V2A051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown