MAUDE Adverse Event Report: CARDINAL HEALTH INFANT HEEL WARMER W/TAPE 4X4; INSTANT WARM PACK

Model Number 11460-010T

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

Since the lot number could not be provided a review of the specific device history record (dhr) could not be completed.Since no sample was provided a more detailed investigation could not be completed.However, the plant¿s quality system mandates suitable in-process controls to measure seal integrity of representative samples.Fifty-five samples are pulled during production of each lot and tested at predetermined locations to best gauge the seal integrity by pull test and functional leak testing.All samples pulled during the manufacture of each lot, must meet the predetermined criteria before it will be released.It should be noted that the solution used in the product is food grade and not considered a safety risk.In addition, the product does not produce a gas or an output that would cause it to ¿blow¿.Since no sample was returned for this complaint, the failure mode could not be determined.(b)(4).

Event Description

Registered nurse (labor and delivery) tried to activate the infant heal warmer and the package "blew up" in her face.The customer did not keep the product.

• Brand Name: INFANT HEEL WARMER W/TAPE 4X4
• Type of Device: INSTANT WARM PACK
• Manufacturer (Section D): CARDINAL HEALTH; 808 highway 24 w; moberly MO 65270
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5344711
• MDR Text Key: 35538634
• Report Number: 1423537-2016-00001
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

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: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR