MAUDE Adverse Event Report: COVIDIEN MH00002T; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number MH00002T

Device Problem Explosion (4006)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

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

The customer reported that the nurse was in the process of activating an infant heel warmer to prepare for a blood glucose.During the activation process the warmer exploded and spewed its contents on the nurse and many objects in the vicinity including the father of the baby.Additional information received from the customer stated that there was no harm occurred to the staff or the patient involved.No medical intervention or treatment required.

Manufacturer Narrative

A review of the device history record was not possible during this investigation as a viable lot number was not received with the complaint.Because there was no viable lot number, a date of manufacture could not be determined.All device history records are reviewed and approved by quality prior to release of product.There were no samples received with this complaint therefore an examination of the defect could not be made.From a root cause perspective, with no lot number it is not possible to determine if there were issues during production which could have resulted in a weak seal.As part of continuous improvements, a formal investigation has been opened to implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa tracking and trending purposes.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process and visual acceptance sampling are performed in the plant are in place to prevent non-conforming product from leaving the manufacturing operations.

• Brand Name: MH00002T
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11421170
• MDR Text Key: 234917590
• Report Number: 1219103-2021-00318
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 04/22/2021
• Patient Sequence Number: 1