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

Model Number MH00002T

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2018

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.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 product was found to be cracked when they removed it from the box.

Manufacturer Narrative

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 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.Samples were received in the form of six (6) heel warmers, without the packaging cases.The heel warmers are not accompanied by their original packaging, therefore no lot number is associated with the samples received.Previous investigations for other activation issues 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.Because previous heel warmer investigations have determined that the product is routinely removed from the outer protective packaging this complaint will be considered confirmed and non-manufacturing related.Additional end use storage information was requested to provide clarification for this event.No information was provided.From a root cause analysis perspective, possible reasons for the heel warmers to pre-activate in the field can include: 1)there are slight pin holes in the teflon seals that separate the sodium acetate and water pouches.Because no finished good lot number was provided, a detailed review of raw material differences cannot be performed, as there is no way to trace back to a raw material lot number 2) sodium acetate crystals are being caught in the sealing process of the heel warmers during the manufacturing process.If the sodium acetate is trapped in the seals and dislodged it would activate before packaging.Our current inspection process in place has implemented inspections for these defects.3) packaging of the product occurs twenty-four hours after product has been produced.Product will be 100% inspected at the time of twenty-four hour packaging for pre-activation.100% inspection for pre-activation is performed by pallet.Any product exhibiting signs of obvious damage or pre-activation are scrapped.If the sodium acetate is trapped in the seals and has not been dislodged, no pre-activation would occur unless the product is mishandled during logistics, distribution centers and/or at the end user to cause the sodium acetate to dislodge from the seals 4) 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.No formal corrective or preventive actions will be taken at this time.All inspections have already been implemented to detect the issue of pre-activation.Any additional pre-activation may be attributed to the miss-handling/ storage of the product.The reported customer complaint is confirmed.A root cause could not be determined.The most probable root cause is determined to be the transport and storage practices of the product prior to use.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: 7893559
• MDR Text Key: 121865271
• Report Number: 1219103-2018-00209
• 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: 11/28/2018

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: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 11111111
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 11/28/2018
• Patient Sequence Number: 1