MAUDE Adverse Event Report: COVIDIEN HL WMR 3.5 X W/TAB 25/B 100/C; HEEL WARMER

Model Number MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had a issue with a heel warmer.The customer states the nurse was holding the heel warmer parallel to the floor, close to her body when she squeezed the heel warmer to activate the product.The heel warmer ruptured out the bottom, spraying fluid onto the nurse at the mid-level of her body.Some of the solution came in contact with the infant.No one was hurt, the fluid was cleaned off the infant and the nurse cleaned off her scrubs.

Manufacturer Narrative

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

• Brand Name: HL WMR 3.5 X 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 dr.; chicopee MA 01022
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3975383
• MDR Text Key: 4821041
• Report Number: 1219103-2014-00020
• 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
• Report Date: 06/11/2014

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 06/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1