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

Model Number 71-1105

Device Problems Suction Problem (2170); Infusion or Flow Problem (2964)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Root cause: a deroyal suction canister was not in use at the time of the event.Another manufacturer's canister was in use.Corrective action: a corrective action has not been taken.Investigation summary: a medwatch report ((b)(4)) was received indicating that a deroyal suction canister (finished good 71-1105) was not providing adequate suction during a procedure.This issue was entered as an internal complaint (call (b)(4)) and investigated.To complete the investigation, deroyal's investigator looked up the reporting customer's shipment history to obtain recently shipped lot numbers to determine if there were any actions that could potentially result in the reported failure.It was discovered that the reporting customer has not purchased (b)(4).The affected part that was reported to the fda as failing.A deroyal sales representative visited the reporting customer june 10, 2019, and contacted (b)(6), the user facility's risk manager who initially reported the incident to the fda.Ms.(b)(6) informed the deroyal representative that another device manufacturer had performed in-servicing for the reported issue, thus confirming that the defective device was not in fact a deroyal suction canister.The investigation is complete at this time.If new or critical information is received, this report will be updated.

Event Description

During a bedside bronchoscopy, an issue with the suctioning device arose.There was not adequate suction through the scope.Wall mount was changed, scope was switched out, multiple canisters were also changed.After confirming that the wall suction was adequate and the scope in working order, dr.Noted that the suction after the canister was not strong enough.There seems to be an inadequate seal on the current canisters to allow the suction to work appropriately.Anesthesia was in the room and he stated that this has occurred multiple times in the or as well.Though the patient was not injured in any way, this could have posed a serious threat if the procedure was more in depth.

• Brand Name: SUCTION CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 8739173
• MDR Text Key: 214134641
• Report Number: 1057404-2019-00001
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00749756049146
• UDI-Public: 00749756049146
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71-1105
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2019
• 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 Age: 78 YR