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

Model Number MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: january 16, 2019.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 states they have had reports of the infant heel warmer exploding on the nursing staff and infants when they are being activated.

Manufacturer Narrative

No lot number was provided.A review of the device history record (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.During production all product is held and 100% inspected after manufacture to ensure that no pre-activation or leaking occurs.Any product exhibiting signs of obvious damage or pre-activation are scrapped.Possible reasons for the heel warmers to ¿puncture finger¿ were evaluated.The heel warmers are not made of any sharp objects to allow skin to be ¿punctured¿.The pouch material is made of poly bag material for the backing and 48 gauge polyester/polyethylene blend for the front pouch stock.This material is thinner and may potentially cause ¿paper cuts¿ if gloves are not worn during handling.Possible reasons for the heel warmers to burst in the field were evaluated.One potential root cause 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 in 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 cases 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.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.Previous investigations for burst issues revealed that once the product is received in the distribution centers, the product is removed from their cases and cartons, placed in bags and distributed to the required medical facility.The product being exposed to logistic movements may cause activation or wear on the seals if they are not handled as fragile.Since they may be subject to removal from their original protective packaging for transit and/ or distribution, no manufacturing related root causes can be determined.The product may have been hit against a surface putting too much force on the pouch during shipment.Because this heel warmer was potentially mishandled during logistics this complaint will be considered not 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.The reported customer complaint could not be confirmed.A root cause could not be determined.The most probable root cause was determined to be the mishandling and misuse of the product during logistics and storage.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.

• 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: 8252661
• MDR Text Key: 133218901
• Report Number: 1219103-2019-00220
• 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: 02/27/2019

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
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 02/27/2019
• Patient Sequence Number: 1