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 Problems Eye Injury (1845); Foreign Body In Patient (2687)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

The device history record review was completed on the reported lot v7d309.The lot was found to have been manufactured and released to predetermined specifications.  no anomalies were found during review of the records.1000 infant heel warmer samples were received by the site on (b)(6) 2017 out of which 500 samples were in their original packaging labelled with lot # v7d309.The remaining 500 were in an open plastic bag.The quality engineer visually inspected all the samples and 2 had incomplete top seal which most likely caused the incident to occur.The most likely cause for this incomplete seal to occur would be seal bar malfunction.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, the plant has started a more detailed investigation (corrective and preventive action 084).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 received from the customer the nurse was activating the infant heel warmer and it burst splashing into the nurses eye and mouth.She performed an eye wash to irrigate her left eye and rinsed her mouth.She was examined and it was recommended she get lubricants from the employee pharmacy for her eye.

• 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: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6600672
• MDR Text Key: 76269217
• Report Number: 1423537-2017-00098
• 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
• Type of Report: Initial
• Report Date: 05/31/2017

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: V11460-010
• Device Catalogue Number: V11460-010
• Device Lot Number: V7D309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/10/2017
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 68