MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS INFANT HEEL WARMER SQUEEZE; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Customer reported nurse was squeezing to active the heel warmer when the bag exploded into her face, hair, chest, and abdomen.No injury reported.

Manufacturer Narrative

The sample was not returned for investigation; therefore, the root cause remains unknown.Device history record review was completed on the reported lot number v2s056.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No further action will be taken at this time.Cardinal health will continue to monitor complaint trends for this reported issue.

• Brand Name: NOVAPLUS INFANT HEEL WARMER SQUEEZE
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• 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: 16812632
• MDR Text Key: 313992742
• Report Number: 1423537-2023-00914
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10192253061468
• UDI-Public: 10192253061468
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: V2S056 E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female