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

Catalog Number V71-6515

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

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

Event Date 12/19/2013

Event Type  malfunction  

Event Description

The hospital reported that the suction stopped working during the case.Facilities and biomed were called.Facilities found bio-hazardous materials behind the wall plate that had to be cleared, which had dried over with several uses.Suction measuring at 20 out of 21 per engineer.Suction regulator evaluated by biomed was functioning as appropriate.Related loss of suction at liner canister.

Manufacturer Narrative

Deroyal: the root cause for this reported issue could not be determined due to the sample not being provided for evaluation, the lot number not being reported, no external suction issues have been reported for the 1500cc safeliner in the past 12 months, and no internal issues related to testing of the 1500cc safeliner have occurred.

• Brand Name: DEROYAL
• Type of Device: KDQ BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; powell TN
• Manufacturer Contact: courtney rinehart ; 200 debust ln; powell, TN 37849 ; 8653622122
• MDR Report Key: 3666840
• MDR Text Key: 4347431
• Report Number: 1057404-2014-00003
• 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: 12/19/2013
• 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