MAUDE Adverse Event Report: CARDINAL HEALTH WARMERS, INFANT HEEL W/TABS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number MH00002T

Device Problem Explosion (4006)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the pack ruptured during activation.There was no harm reported.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.Since a lot number was not provided, a date of manufacture could not be determined.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.However, there have been complaints reported in the past for burst pouch.The most probable root cause could be there was too much heat applied or an issue with the raw material.It is important to note that a series of tests are performed during every lot of production.More specifically, inspections are performed to test the seal strength for both the inner seal, where the product would activate and the outer seal.During the test, the pouch is first activated, and the inner seal is broken.The pouch is then placed between two plates.The pouch is compressed until the pressure required per the procedure is reached, 350 lbs minimum.The pouch is left to dwell in the machine for 20 seconds, using a calibrated stopwatch to time it.After the dwell time, the pouch is removed and visually inspected for leaks or spreading of the seam.A pouch with any issues would be rejected at this time and the machine adjusted.If the pouch passes the dwell test it is returned to the machine and the pouch is then compressed until the pouch breaks or reaches over 1000 pounds.The value is then recorded.As part of continuous improvements, a corrective and preventative action (capa) has been opened to address the reported issue through a more robust investigation.The results of investigation have been documented through the referred capa.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: WARMERS, INFANT HEEL W/TABS
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13542806
• MDR Text Key: 285688133
• Report Number: 1219103-2022-00346
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• 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: 03/24/2022

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 Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1