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); Chemical Exposure (2570)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review could not be performed as the lot number was not provided.Nine infant heel warmer samples were received by the site on (b)(6) 2017.All the samples received were not activated.Site quality engineer (qe) visually checked all the samples for seal issue and all of them met the visual inspection criteria.Qe then activated all the samples and none of them burst or leaked.Given the nature of this complaint, plant has started a more detailed investigation (corrective and preventive action 084).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.  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 from the customer the infant heel warmer burst and went into the patient¿s eye.  it is unknown what type of treatment was provided to the patient.

• 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: 6556879
• MDR Text Key: 74827505
• Report Number: 1423537-2017-00090
• 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: Medical Technologist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/10/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2017
• Initial Date Manufacturer Received: 04/16/2017
• Initial Date FDA Received: 05/10/2017
• 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