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 Patient Involvement (2645)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Submitted: september 24, 2018.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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports the heel warmer exploded when activated.The white gel spilled on the nurses uniform, onto the wall, and the computer.There was no patient involved.

Manufacturer Narrative

Correction: lot number: original lot number provided was deemed incorrect.The lot no.Is therefore being reported as unknown.The lot number provided with this complaint is deemed incorrect.The provided lot number, ch42sp41605, is a raw material part that is pre-printed on the heel warmer pouch material.This number does not provide traceability to the product lot number.Therefore, this event will be evaluated as having an unknown lot number.No traceable 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 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.No product/sample was provided for evaluation due to being discarded by the reporting facility.No additional information, pictures or videos were received.Without a product sample, further investigation could not be conducted.Previous investigations for burst issues indicated 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.Because this heel warmer was potentially mishandled during logistics and activated against the instructions on the provided packaging and artwork, this complaint cannot be confirmed and is not considered manufacturing related.Additional end use storage information was requested to provide clarification for this event.No information was provided.Additional causes for the heel warmers to burst in the field may include 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.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 is not confirmed.The root cause for this reported issue was determined to be end use handling/misuse and/or storage of the product.This complaint will be used for tracking and 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: 7901505
• MDR Text Key: 121451827
• Report Number: 1219103-2018-00211
• 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
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 11/30/2018
• Patient Sequence Number: 1