MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Model Number 66800041

Device Problems Material Rupture (1546); Material Separation (1562)

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

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Our reference number: (b)(4).

Event Description

It was reported that during the use of the versajet, a patient was undergoing an excision for 3rd degree burns and disassociation of the hose from the water flow at the lock (sterile part) was observed.The problem occurred after 30 minutes of use.The intervention was completed with a new versajet kit.There were no consequences for the patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A relationship between the report event and device could be established.A visual inspection was performed and showed the feed line hose was received detached from the pump cartridge.There did not appear to be any residual adhesive within the feed line where it would connect to the pump cartridge fitting.Root cause is determine to be a manufacturing process error.This failure is considered to be isolated.Functional inspection was performed and showed the feed line was connected to the feed line fitting within the pump cartridge.The unit then primed and cut.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11401836
• MDR Text Key: 234394446
• Report Number: 8043484-2021-00450
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50836959
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1