MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; PACK, HOT OR COLD, DISPOSABLE

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 326050874
• Report Number: 1423537-2023-00998
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380057588
• UDI-Public: 10885380057588
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V2P199
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1