MAUDE Adverse Event Report: COVIDIEN HL WMR 3. 5X5 W/TAB 25/B 100/C; HEEL WARMER

Model Number MH00002T

Device Problems Material Rupture (1546); Self-Activation or Keying (1557)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a heel warmer.The customer reports pt and/or technician exposure to the enclosed solution as a result of the heel warmer pack rupturing under pressure without activation being achieved.Product cleanup and exposure instruction provided on the pack were followed.The customer further stated that an sds was obtained.

Manufacturer Narrative

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

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 release of product.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A formal corrective and preventive action (capa) was initiated to determine the root-cause, determine and implement the corrective action(s), and verify the effectiveness of the action(s).While unable to directly confirm that the nature of the described incident is completely aligned with the issue for the referenced capa, it is highly likely that the incident is the same or similar to the issue being solved via the capa.Within the scope of the capa, the root cause has been determined to be the purchased back of pouch material.In the 'supplier process, there was a weak lamination between the polyester and the polyethylene layers that comprise the back of the pouch material for the last lot of material supplied, which caused the noted bursting phenomenon experienced by the customer.Corrective and preventive actions have been completed to integrate the supplier performed laminate peel test and burst test into the raw material purchase specification (rmps) for the back of pouch material.Specification values around these tests were modified in accordance with acceptable performance as well.This complaint will be shared with the charts/sensors/hydra focus factory to promote awareness and help prevent recurrence, and we will continue to trend for similar reports.

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 release of product.On september 22, 2014, ten (10) new (non-activated) customer returned samples were evaluated.The actual reported complaint sample was not returned.Eight (8) of the ten samples were activated per the approved process by applying pressure and squeezing from the bottom of the pouch as identified on the product labeling.All eight returned samples activated as intended with no leaking or bursting during activation.The remaining two (2) returned samples were activated per the incorrect process by applying pressure and squeezing from the top of the pouch.Both samples burst through the bottom seal as expected, as this is not the proper method to activate the infant heel warmer.Due to our investigation, specifically to this complaint, we can understand how the infant heel warmer ruptured due to an improper method used to activate the heel warmer.It is important to review the safety and how to activate instructions printed on the pouch while using this product.This complaint will be shared with the charts/sensors/hydra focus factory to promote awareness.This complaint will also be used for trending and tracking.

• Brand Name: HL WMR 3. 5X5 W/TAB 25/B 100/C
• Type of Device: HEEL WARMER
• Manufacturer (Section D): COVIDIEN ; two ludlow park dr.; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4002295
• MDR Text Key: 18001428
• Report Number: 1219103-2014-00023
• Device Sequence Number: 1
• Product Code: MPO
• 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,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2014

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: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/03/2014
• Supplement Dates Manufacturer Received: 09/24/2014; 09/24/2014
• Supplement Dates FDA Received: 09/04/2014; 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1