MAUDE Adverse Event Report: DECON LABS CITRASOLV

Lot Number 442167

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem Tissue Damage (2104)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

Citrasolv (decon laboratories) reagent was contaminated with gray-green to brown mucoid like substance which interfered with the clearing of tissue processed at the (b)(4).This resulted in tissue damage that requires re-processing (which is in process) at the minimum.Dates of use: (b)(6) 2016.Diagnosis or reason for use: used to clear tissue before paraffinization of tissue.Tissue is then cut and placed on slides for diagnosis.

• Brand Name: CITRASOLV
• Type of Device: CITRASOLV
• Manufacturer (Section D): DECON LABS ; 460 glennie circle; king of prussia PA 19406
• MDR Report Key: 5868015
• MDR Text Key: 100770581
• Report Number: MW5064007
• Device Sequence Number: 1
• Product Code: KEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 442167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other