MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; 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	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no samples were returned for evaluation, a root cause could not be determined.Device history record review was completed on the reported lot v2p199.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health has made a business decision to close the site which manufactures product v11460-010 and transition to a third-party manufacturer.Cardinal health will continue to monitor and trend all reported product related issues for this product.
Event or Problem Description
Customer reported the hot pack exploded while nurse was performing test on newborn.The contents did not come into contact with newborn or nurse's skin.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• 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: 17965776
• Report Number: 1423537-2023-00998
• Device Sequence Number: 7754317
• Product Code: IMD
• UDI-Device Identifier: 10885380057588
• UDI-Public: 10885380057588
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/19/2023

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: V2P199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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