MAUDE Adverse Event Report: DEROYAL INDUSTRIES OUTER SHELL CANISTER, 300CC, BRACKET; BOTTLE, COLLECTION, VACUUM

Catalog Number 71-3000BR

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

The canister was on the anesthesia cart with the suction line on.They were not using it at the time.The can imploded from the suction.It was a loud pop sound.

• Brand Name: OUTER SHELL CANISTER, 300CC, BRACKET
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: 200 debusk lane; powel, TN 37849 ; 8653622333
• MDR Report Key: 4040610
• MDR Text Key: 4901587
• Report Number: 2320762-2014-00015
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71-3000BR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 07/09/2014
• 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): Required Intervention