MAUDE Adverse Event Report: COVIDIEN "WARMERS, INFANT HEEL W/TABS"; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number MH00002T

Device Problem Explosion (4006)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the heat pack was being activated.When squeezing the heat pack, it exploded on the arms, scrubs and on the face.A second heat pack was squeezed and the same thing has happened.The product from the heat pack was on the customer, over the floor and a nearby wall and on the table.The customer further stated that the skin was washed and the scrubs were changed.There was no harm to the patient or the staff involved.

• Brand Name: "WARMERS, INFANT HEEL W/TABS"
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10203212
• MDR Text Key: 196675596
• Report Number: 1219103-2020-00297
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• 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,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2020

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: Other
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 005746X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 06/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1