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

Model Number 11460-010T

Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670)

Patient Problems Corneal Abrasion (1789); Foreign Body In Patient (2687)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

A device history review could not be performed as the lot number was not available.Since no samples were available, the root cause could not be determined.The plant¿s 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.Given the nature of this complaint, plant has started a more detailed investigation (corrective and preventive action 084). capa 084 has been opened to address this issue.As a containment action, plant has 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 received from the customer, a staff member had an infant heel warmer burst and some of the contents went into their eye upon activation.  per the contact at the hospital the nurse received a corneal abrasion and was seen by her eye doctor.The treatment is unknown.

• 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: 6567296
• MDR Text Key: 75169978
• Report Number: 1423537-2017-00093
• 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: other,user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/15/2017

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: Nurse
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/20/2017
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/15/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other