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

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2021

Event Type  malfunction  

Event Description

The deroyal suction cannisters are defective in connecting the lid to the cannister.There were 3 instances where staff were unable to put the lid on, therefore not creating a suction.This can be a patient safety issue when trying to suction a patient emergently and not being able to because of the lack of suction.This could also expose nurses and critical care techs and cnas to secretions that aren't contained in the cannister.The nurse tried 3 different cannisters to get a new hook up for suction for her unstable patient, and was not able to get a seal with the suction, therefore having to go into our supply room 3 different times when her patient was unstable.

• Brand Name: SUCTION CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13522923
• MDR Text Key: 285543363
• Report Number: 13522923
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1