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

Model Number MH00002T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/20/18 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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the product broke on baby's skin while trying to activate the heel warmer by punching it.The heel warmer exploded on nurse, the baby, and another nurse.The solution crystallized on the baby.The baby was then washed multiple times and the crystals kept reforming.Additional information from the customer states the crystals have since went away from the patients skin and there was no harm/injury to the patient of staff.

Manufacturer Narrative

Submission date: 11/08/2018 an investigation was performed for the reported customer complaint: ¿the customer reports the product broke on baby's skin while trying to activate the heel warmer by punching it.The heel warmer exploded on nurse, the baby, and another nurse.The solution crystallized on the baby.The baby was then washed multiple times and the crystals kept reforming.Additional information from the customer states the crystals have since went away from the patients skin and there was no harm/injury to the patient or staff.¿ no lot number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are in place to prevent nonconforming product in the manufacturing process.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 rejected.Samples were not expected as they were discarded by the reporting facility.No evaluation was able to be performed.However, from a root cause analysis perspective, it could be concluded that the root cause for this reported issue was end use handling/ misuse of the product.This is based on the description of the reported condition indicating that the heel warmer was activated by ¿punching it¿ over an infant.The instructions indicate to squeeze and apply pressure, in the place indicated with the blue border, also depicted in the heel warmer artwork.¿punching¿ it above a patient would be considered misuse of the product.With regards to the description of the reported condition of ¿the solution crystalized on the baby.The baby was then washed multiple times and the crystals kept reforming.¿ the sodium acetate crystals that are part of the heel warmer solution is a water soluble chemical; when a chemical is water soluble and water is added (to clean off the baby) the crystals will continue to form.Water soluble chemicals continue to react when added to water, it absorbs the water into the crystals and continues to become a liquid/ gel type material.The chemical reaction occurred with water as intended and there are no abnormalities confirmed with this description of the issue reported.Additional contributors and potential root causes for the heel warmers to burst include the storage and handling of the product once it leaves the distribution center.During previous investigations for other reported burst issues it was reported that once the product is received in the distribution center, 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.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.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.Heal warmers should be stored in their original packaging until immediately prior to use.Additional end use storage information was requested to provide clarification for this event.No response/information was provided.Due to this heel warmer being mishandled and activated against the instructions on the provided packaging and artwork, this complaint will be considered not confirmed and not 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.It is also recommended that training be provided to the end users for proper safety and activation precautions as indicated on the provided artwork.The reported customer complaint could not be confirmed.A root cause was determined to be end use handling/ misuse of the product.This complaint will be used for tracking and trending purposes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: ARGYLE
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 7893432
• MDR Text Key: 120854683
• Report Number: 1219103-2018-00020
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

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: MH00002T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 11/08/2018
• Patient Sequence Number: 1