MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS TRUUWAVE TUBING 3CC/84 INCH CVP TUBING; TRANSDUCER, PRESSURE, CATHETER TIP

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

While attempting to use cvp tubing, there was a plastic piece of plastic in the cvp stopcock.It was preventing usage.Unable to remove the plastic blockage.Tubing removed and procedure carried out without difficulty.No known harm to patient.Edwards truwave 3cc/84 in cvp tubing.Manufacturer response for truwave tubing, edwards truwave tubing 3cc/84 inch cvp tubing (per site reporter).Will obtain.

• Brand Name: EDWARDS TRUUWAVE TUBING 3CC/84 INCH CVP TUBING
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16536552
• MDR Text Key: 311219410
• Report Number: 16536552
• Device Sequence Number: 1
• Product Code: DXO
• 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: 02/27/2023

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: Health Professional
• 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: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1