MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 1500CC CRYSTALINE RIGID SUCTION CANISTER; BOTTLE, COLLECTION, VACUUM

Catalog Number 71-1101

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

A root cause for the reported inability to create a vacuum cannot be determined at this time due to the lack of samples returned for evaluation.In the event a defective sample becomes available, the case will be reopened.Corrective action: a corrective action is not being taken at this time due to the inability to determine a root cause.Investigation summary an internal complaint (call (b)(4)) was received reporting that a 1500 cc rigid suction canister (finished good (b)(4)) failed to keep suction during use.A sample was not returned for evaluation.However, inventory at the manufacturing site was functionally tested to ensure it performed as intended.An intermittent vacuum test was performed at 40mmhg and a vacuum decay test performed at 11.8 in.Hg.All samples functioned as intended.Flow testing was performed as well to ensure adequate flow through the vacuum port of the lid.Visual inspection of inventory also was performed to ensure lids were fully formed.Year to date, (b)(4) cases ((b)(4) eaches) of the finished good part number have been shipped from deroyal.The ratio of complaints to sales is (b)(4) percent.Preventive action: a preventive action is not being taken at this time due to the inability to determine a root cause.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The customer reported a small batch failed to keep suction.The lids didn't create a vacuum when the negative pressure was applied.This created an issue in the cardiac cath lab because the product failed during use on a patient.

• Brand Name: 1500CC CRYSTALINE RIGID SUCTION CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5808486
• MDR Text Key: 49976782
• Report Number: 2320762-2016-00010
• 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: Other
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71-1101
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• 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