MAUDE Adverse Event Report: TRINITY MEDICAL DEVICES INC. NEOGUARD REFLECTORS; WARMER, INFANT RADIANT, REFLECTOR

Model Number 3008595

Device Problems Melted (1385); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

Neoguard thermal reflector provided by cas medical systems was being used in the nicu without problems.The inventory was dropping and a reorder was issued to cas medical systems.The facility was notified of a backorder.Once the backorder was filled the product arrived and was placed into use.The staff noted that the product that filled the backorder was harder to peel, more sticky and harder to remove from the patient.In addition the humidity in the isolette melted the thermal cover and the product was hard to remove from the patient.There was no harm to the patient.On closer inspection, the packaging of the replenished product while the same graphics, color, and name of the product in small print, it was noted the product now to be provided by trinity medical with a tagline in small print on the packaging: "same product, new owner".The product was removed from use in all areas and additional products are under trial use for selection of a new product.Manufacturer response for thermal reflector, neo guard thermal reflector (per site reporter): the contract coordinator for the facility was to notify the vendor and register a product complaint.

• Brand Name: NEOGUARD REFLECTORS
• Type of Device: WARMER, INFANT RADIANT, REFLECTOR
• Manufacturer (Section D): TRINITY MEDICAL DEVICES INC.; 1 pluckemin way; bedminster NJ 07921
• MDR Report Key: 7243712
• MDR Text Key: 99127323
• Report Number: 7243712
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3008595
• Device Catalogue Number: 4200
• Device Lot Number: 081731579A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1