MAUDE Adverse Event Report: COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW HL WMR 3. 5X5 W/TAB 25/B 100/C; HEEL WARMER

Model Number MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 06/07/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with the heel warmer.The customer reports, the incident occurred in a hospital (b)(6).The customer states, the nurse picked up the heel warmer, was proceeding to walk back to the infant, and with very little pressure to activate, the heel warmer exploded in the nurse's face and on the ceiling.The infant was not harmed.The nurse was sent to the er for medical treatment.The customer reports, the nurse was prescribed erythromycin for her eyes.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The dhr (device history record) for this part number mh00002t lot number 321826x was reviewed.It did not reveal any unusual circumstances that may have led to the issue at hand.All run parameters and acceptance criteria were within acceptable limits.Samples were returned in the form of two heel warmers.One was pre-activated, and the other is unused.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).It is highly likely that the incident described by the customer 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 are being 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

The report was initially submitted as a malfunction, but should have been filed as a serious injury.

• Brand Name: HL WMR 3. 5X5 W/TAB 25/B 100/C
• Type of Device: HEEL WARMER
• Manufacturer (Section D): COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW; 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: 3955752
• MDR Text Key: 4629430
• Report Number: 1219103-2014-00016
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2014

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: MH00002T
• Device Catalogue Number: MH0002T
• Device Lot Number: 321826X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: 07/27/2015; 07/27/2015; 07/27/2015
• Supplement Dates FDA Received: 07/16/2014; 09/02/2014; 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1