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

Model Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problems Itching Sensation (1943); Caustic/Chemical Burns (2549)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

The device history record could not be reviewed, as the lot number was unknown.No samples were available for evaluation, therefore, 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 has been initiated.Capa (b)(4) 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 reported by the customer a nurse was trying to activate the infant heel warmer when it burst, splashing onto her hands and forearms.She had burning and itching to her forearms.She went to the emergency department and the emergency department physician sent her home for the rest of the day.No other information could be obtained from the customer.

• 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: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6623697
• MDR Text Key: 77222325
• Report Number: 1423537-2017-00103
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

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?: No
• Distributor Facility Aware Date: 05/16/2017
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/08/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other