MAUDE Adverse Event Report: MO016 MO-MOBERLY INFANT HEEL WARMER SQUEEZE 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	11460-010T
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that a lab tech was preparing to use a cardinal health infant heel warming pack.When she squeezed the pouch as directed for use the pack burst in her face.The contents went into her right eye, nose, and mouth.She was immediately taken to the eye wash station where she continuously rinsed the eye as well as rinsed her mouth several times.The remaining substance was wiped from her face, and she was transferred to the emergency room.The issue resulted in a scratch on her eye and a follow up with ophthalmology.She was given an antibiotic eye drop and missed one day of work.She is doing well and there are no residual issues.
Additional Manufacturer Narrative
The complaint indicated that samples were not available.Without a sample the root cause cannot be determined.Device history record review was completed on the reported lot v3b283.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the record.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: INFANT HEEL WARMER SQUEEZE 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17834463
• Report Number: 1423537-2023-00991
• Device Sequence Number: 7695341
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V3B283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female