MAUDE Adverse Event Report: COVIDIEN HL WMR 3.5X5 NO TAB 25/B 100/C; HEEL WARMER

Model Number MH00002N

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 07/09/2014

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 that the heel warmer exploded upon activation.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

This complaint is for product mh00002n, with an unknown lot number.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 capa (corrective and preventive action), 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.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.

• Brand Name: HL WMR 3.5X5 NO TAB 25/B 100/C
• Type of Device: HEEL WARMER
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; 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: 4176224
• MDR Text Key: 5153347
• Report Number: 1219103-2014-00024
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

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: MH00002N
• Device Catalogue Number: MH00002N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1