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

Model Number 66800041

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

Device was faulty causing saline to expel from the tubing that connects to the machine.

• Brand Name: VERSAJET II EXACT 45 DEGREE/14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15713831
• MDR Text Key: 302843694
• Report Number: 15713831
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50938700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White