MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; INDICATOR, BIOLOGICAL STERILIZATION PROCESS

Catalog Number LCB020

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2016

Event Type  malfunction  

Event Description

Vials in packaging prematurely ruptured.The media leaked out of the vial into the foam packaging.There is no damage to the exterior container.Storing by our facility is in alignment with the manufacturers ifu.This is not the first time this occurred as we have received and reported it at least 2 other times.The first was winter so we suspected it frozen, this is no longer the thought.The manufacturer has been informed of this issue.They feel it may be due to the distribution center as they have not received other reports.In talking with another facility, they had also reported this issue one time.

• Brand Name: VERIFY
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): STERIS CORPORATION; 11457 melrose ave.; franklin park IL 60131
• MDR Report Key: 6069163
• MDR Text Key: 58850920
• Report Number: 6069163
• Device Sequence Number: 1
• Product Code: FRC
• 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: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/17/2016
• Device Catalogue Number: LCB020
• Device Lot Number: 161217E
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1