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

Model Number V11460-010

Device Problem Burst Container or Vessel (1074)

Patient Problem Eye Injury (1845)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

A device history review could not be completed, as no lot code was available.  since no sample has been returned, we cannot determine a failure mode or definitive root cause.The plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.Currently, eighty-six samples are being tested for each lot produced of this product at predetermined locations to best gauge the seal integrity by pull test and functional leak testing.All samples pulled from these lots meet the predetermined criteria before they are 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 explode and the chemicals used in the product are food grade and non-toxic.While there was no sample available to address this specific complaint, cardinal health conducted a stock check at its distribution centers to check the product and ensured that there are no product quality issues with the seals of the product.We continue to monitor and maintain awareness of the operators to ensure proper seals are made during production. .

Event Description

Based on the report from the customer the heel warmer burst at the bedside.The contents of the heel warmer went into the rn's eye. she was assessed in the emergency department and followed up with her eye doctor. she did not experience any permanent injury.

• Brand Name: NOVAPLUS INFANT HEEL WARMER 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: 6336465
• MDR Text Key: 67608389
• Report Number: 1423537-2017-00072
• 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
• Report Date: 02/16/2017

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: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/24/2017
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other