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

Model Number MH00002T

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports heel warmer leaked during use.

Manufacturer Narrative

A sample was received for evaluation.The pouch is clearly leaking the activated solution into the containment bag that the sample was sent in.One potential cause for a heel warmer burst is the storage and handling of the product once it leaves the distribution center.The individual pouches do not have identifying lot numbers, so lot to lot identification for issues is unable to be determined for this reported condition.The heal warmers should be stored in their original packaging until immediately prior to use.It is important to note that the heel warmer product case labels and pouches are labeled as fragile, so care is needed during the shipment, storage and use of product.Packaging instructions also provide vital information for intended use.Because this heel warmer was potentially mishandled while in-transit to the end user, this complaint will be considered un-confirmed and non-manufacturing related.It is recommended that the end user identify corrective actions with the appropriate distribution centers to ensure their products are transported and stored in the protective cases/cartons and stored as such until ready for use.These actions will prevent heavy or sharp objects from inadvertently causing damage to the seals of the product before arrival or during storage at the medical facility; as well as maintain the integrity of the seals.No formal corrective or preventive actions will be taken at this time as the root cause is likely to the attributed to the mishandling and misuse of the product during logistics and storage.If additional information or samples are received, the investigation will resume as needed.We will continue to trend this issue for future occurrences as part of the complaint review process.

• 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
• MDR Report Key: 8439926
• MDR Text Key: 139443207
• Report Number: 1219103-2019-00228
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 08/05/2019
• Patient Sequence Number: 1