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

Model Number MH00002T

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem Eye Burn (2523)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.¿ if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: during pre admission testing when using a heel warmer for a blood draw the heel warmer burst during activation.The chemical went into the patient's left eye.The patient was a (b)(6) female.Subsequently her eyes were flushed out and she had no further symptoms until the next day when she experienced burning in her eye and temporarily lost vision in the left eye.The patient is now being treated by a specialist.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.Samples were 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 reported condition and determine the root cause.The product is manufactured using a dispense of contents and both horizontal and vertical sealing processes.Two printed polybag liners (front and back) are lined up and sealed.The materials are introduced where the artwork is rotated 90 degrees and the top of the pouch is processed through vertical seal bars.Relative to the finished pouch, the top, bottom and inner seals are created using vertical bar sealers.As the machine moves the materials, the side seals are created using another bar sealer.During the sealing processes, a set of 4 pouches are formed during a machine cycle with 2 pouches from lane 1 and 2 pouches from lane 2.The materials are sealed and cut apart to make four separate pouches during a cycle.The sealers are set up to seal the liners together as they run vertically through the line.This allows for the water and sodium acetate anhydrous to be dispensed and the pouch seal to be completed around it.Without the lot number or sample, it is not possible to determine if there were issues during production which could have resulted in a weak seal.If the lot number or sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.It is also 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 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 action has been opened to address the reported issue.In addition, a quality alert has been issued to raise awareness of the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: WARMERS, INFANT HEEL W/TABS
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11168124
• MDR Text Key: 226743170
• Report Number: 1219103-2021-00311
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 03/10/2021
• Patient Sequence Number: 1