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

Model Number MH00002T

Device Problems Leak/Splash (1354); Explosion (4006)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

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 exploded on the nurse.The nurse rinsed the area and did not feel a need to go to emergency department.

Manufacturer Narrative

(b)(4).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.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.A root cause could not be determined.A probable root cause 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
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8355242
• MDR Text Key: 136713270
• Report Number: 1219103-2019-00225
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1