MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC DEROYAL

Catalog Number 71-1105

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2014

Event Type  malfunction  

Event Description

The hospital reported that fluids were sucked through the vacuum lines contaminating the vacuum lines.After verifying correct hookup, the used canister showed fluid in the vacuum port.

Manufacturer Narrative

Describe event or problem: the hospital reported that fluids were sucked through the vacuum lines contaminating the vacuum lines.After verifying correct hookup, the used canister showed fluid in the vacuum port.The returned sample was evaluated via visual, functional, and dimensional inspections.The only was the reported issue could be duplicated was to initially suction fluid with an incorrect hookup and then use the correct hookup.The root cause could not be determined since the report indicates that correct hookup was verified by the user, and incorrect hookup was the only way deroyal could duplicate the issue.

• Brand Name: DEROYAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC; powell TN
• Manufacturer Contact: courtney rinehard ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3928357
• MDR Text Key: 4530789
• Report Number: 1057404-2014-00007
• 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: 05/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71-1105
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2014
• Date Manufacturer Received: 05/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1