MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; BOTTLE, COLLECTION, VACUUM

Catalog Number V71-6515

Device Problems Contamination (1120); Suction Problem (2170); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

The hospital reported that during a case the liner developed a crack causing fluid to travel into the regulator tubing and up into the wall regulator.

Manufacturer Narrative

Describe event or problem: the hospital reported that the during a case the liner developed a crack causing fluid to travel into the regulator tubing and up into the wall regulator.Deroyal: the root cause was determined to be mishandling of the carton during transit from deroyal to the end user.As a corrective action, deroyal met with personnel at (b)(6) hospital to discuss inspection of the product before use to make sure there are no visible cracks that may have occurred during transit to the end user.

• Brand Name: DEROYAL
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; powell TN
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3666841
• MDR Text Key: 4347434
• Report Number: 1057404-2014-00002
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V71-6515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2013
• Distributor Facility Aware Date: 11/06/2013
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2014
• Date Manufacturer Received: 01/02/2014
• 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
• Patient Outcome(s): Other