MAUDE Adverse Event Report: DEROYAL INDUSTRIES SAFELINER SUCTION CANISTER, SEMI-RIGID, 1500CC; BOTTLE, COLLECTION, VACUUM

Catalog Number V71-6515

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Suction canister was used in a case, and after about three hours, the doctor advised no longer had suction.It looked like it had humidity, and the filter underneath the lid had changed to light tan in color.The customer stated they felt it wasn't normal and changed the canister/lid.Suction seemed to be fine after that.No injury was reported related to the patient.

Manufacturer Narrative

Investigation findings: the qc complaint specialist left a voicemail for the safety specialist on (b)(6) 2015 in reference to the report identifying that the complaint sample was contaminated and not decontaminated prior to the return.The safety specialist responded on (b)(6) 2015 detailing that if the product is unable to be decontaminated prior to return, it will not be approved for the return process.Included within the call was the senior project engineer.The senior project engineer identified that decontamination efforts would damage evidence that would be beneficial to the investigation.It was recommended that additional information be obtained from the reporting customer to assist in the investigation.The qc complaint specialist contacted the reporting customer in an email on (b)(6) 2015 and the following information was requested: was the product being utilized with any additional systems? ex.Cauterizing.You had previously identified it was being utilized with cusa.Does cusa create humidity and provide information as to what is being aspirated? can pictures be provided of the lid and filter? detailing all angles and including a top view through the port on the lid showing the filter.How long have you been utilizing the deroyal product? during use, have you utilized the deroyal product with the cusa system previously? the reporting customer did not adequately respond to the qc complaint specialist's email.A voicemail was left for the reporting customer on 04/28/2015 requesting additional information.As of the date of this report, requests for additional information have not been returned.The qfi report was reviewed for sales and similar complaint information.Deroyal has sold (b)(4) cases of the finished good from 2013 to 2015.During the review period, one previous report detailing a loss of suction was received in 2014.The complaint has been forwarded to the rpp representative for the joint investigation process.Rpp sample review indicates that a residue is present at the filter and the patient port discoloring the areas (picture provided).Correction: none determined at this time.Isolated occurrence.Root cause analysis: based on the returned defective sample, it is concluded the issue is not manufacturing or product failure related.Due to incomplete information regarding the case/environment which the product was used, the investigation cannot be completed at this time.If more information becomes available, the case will be reopened for further investigation.Corrective action and/or systemic correction action taken: none determined at this time.Isolated occurrence.Preventive action: none determined at this time.Investigation is complete at this time.This report will be updated if more information becomes available.

• Brand Name: SAFELINER SUCTION CANISTER, SEMI-RIGID, 1500CC
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4745139
• MDR Text Key: 17210362
• Report Number: 2320762-2015-00008
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V71-6515
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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