MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. INFANT HEEL WARMER

Catalog Number HNICU-100

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: the true root cause of the bag rupturing cannot be determined.The reporting customer failed to identify a lot number, and the defective sample was not returned.Additionally, deroyal provides an instructions for use (ifu) that instructs the user to activate the device away from the face and the infant.Therefore, user error may have contributed to the solution coming into contact with the clinician's eye.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received indicating that an infant heel warmer (part number hnicu-100) exploded upon activation, which introduced the solution into a clinician's eye.The reporting customer did not provide a lot number.Additionally, the defective sample was discarded by the user and, therefore, was not available for evaluation.Due to the absence of a lot number, a work order and device history record review could not be completed.The material safety data sheet (msds) and ifu were evaluated.The msds states that eye protection is not needed under normal use conditions and provides the following instruction: "emergency first aid procedures: if chemical contacts eyes, flush eyes with copious amounts of water." the ifu and the strap of the heel warmer state that the product is to be activated away from the face and the infant.Deroyal has sold (b)(4) of finished good hnicu-100 from 2014 to present.Two complaints (including this report) have been received during the same period for ruptured heel warmers.(b)(4).Deroyal will continue to monitor post market feedback for the device and failure reported and will recognize if a trend develops.Preventive action: due to the root cause determination, a preventive action is not being taken.This investigation is complete.If new and critical information is received, this report will be updated.

Event Description

The item was being used as intended.Once the internal chemical was activated, the warmer bag exploded and got into a clinician's eye.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5953598
• MDR Text Key: 54893950
• Report Number: 2320762-2016-00019
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: HNICU-100
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1