MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC 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 07/15/2022

Event Type  malfunction  

Event Description

Customer reported that when the heel warmer was squeezed to activate, its contents oozed out on associate.No injury reported or other demographics provided.

Manufacturer Narrative

Device history record (dhr) review was unable to be completed as no lot number was available for evaluation.The actual complaint sample was not returned for investigation; therefore, an evaluation of the complaint sample for deficiency of construction could not be performed.The root cause was not determined.We will continue to monitor trends for this product.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• 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: 15481348
• MDR Text Key: 301133104
• Report Number: 1423537-2022-00848
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/23/2022

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 Operator: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female