MAUDE Adverse Event Report: MO016 MO-MOBERLY INFANT HEEL WARMER SQUEEZE 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 11460-010T

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Customer reported that they had two more heel warmers/heat packs burst.No patients or employees were injured or sprayed with the internal contents of the heat pack.After the incident, the staff went through all of the warmers and found more packs with open outer seams and pulled them out of service.

Manufacturer Narrative

A sample was received for evaluation and the defect reported was confirmed.The root cause was determined to be a small hole in the outer pouch due to improper machine setup.Device history record review was completed on the reported lot vsd237, and the lot was manufactured and released in compliance with all requirements.Cardinal health has made a business decision to close the site which manufactures product 11460-010t and transition to a third-party manufacturer.

• Brand Name: INFANT HEEL WARMER SQUEEZE 4X4IN
• 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: 17552982
• MDR Text Key: 321271323
• Report Number: 1423537-2023-00980
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10192253061420
• UDI-Public: 10192253061420
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: VSD237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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