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 Irritation (1941); Blurred Vision (2137)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

A device history record review was completed on the reported lot v7b153.The lot was found to have been manufactured and released to predetermined specifications.  no anomalies were found during the review of the records. one-hundred twenty-one (121) infant heel warmer samples were received by the site on 06/12/2017 out of which 25 samples were in their original packaging labelled with lot # v7b153.The rest of the 96 were in an open plastic bag.The quality engineer visually inspected all the samples and 6 had incomplete top seals which most likely caused the incident to occur.The probable 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, plant has started a more detailed investigation.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, employee had infant heel warmer splash in her eye during activation of the pack.She was seen in occupational health by a physician.  her eye was rinsed.She had blurred vision and eye irritation for 2-3 days following the incident.

• 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: 6636856
• MDR Text Key: 77433787
• Report Number: 1423537-2017-00105
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

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: V7B153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/02/2017
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1