MAUDE Adverse Event Report: CARDINAL HEALTH MOBERLY INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 11460-010T

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review could not be completed, as no lot number was available.One sample was received on 03/24/2017.After analyzing the sample, it was determined that the sample had a runoff seal which caused the incident to occur.Most likely cause for this run off seal to occur would be seal bar malfunction.The manufacturing facilities quality system mandates suitable in-process controls to measure seal integrity of representative samples.Currently, samples are being tested for each lot produced of this product at random intervals to best gauge the seal integrity and functional leak testing.All samples pulled from this lot met the predetermined criteria before it was released.It should be noted that the hot packs do not have any type of chemical or gaseous component that would cause the pack to burst and the chemicals used in the product are food grade and non-toxic.A capa has been opened to address this reported issue and as a containment action, the manufacturing facility has implemented a 100% inspection at the line to check for any seal issues that might cause burst/leakage prior to packaging of the product.

Event Description

Based on information from the customer, an employee accidentally squeezed the contents of the infant heel warmer, into her eyes.The infant heel warmer the employee was using had a diagonal seam that ended very close to the top of the package.When she attempted to activate the warmer, the force of her squeeze pushed the contents of the package up and out into her eyes.On the backside of the package, it instructs the user to flush their eyes and consult a physician.After flushing her eyes, the employee complained of burning and grittiness so she was sent to the doctor and prescribed antibiotic eye drops.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6479734
• MDR Text Key: 72339427
• Report Number: 1423537-2017-00081
• 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
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/20/2017
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR