MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC; STOPCOCK, I.V. SET

Lot Number 63673283

Device Problems Pacing Problem (1439); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2021

Event Type  malfunction  

Event Description

Stopcock on art line was defective.Wave form was not readable.Line had to be changed and waveform improved.

• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13042844
• MDR Text Key: 282498447
• Report Number: 13042844
• Device Sequence Number: 1
• Product Code: FMG
• 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: 10/28/2021,10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 63673283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4015 DA
• Patient Sex: Male
• Patient Weight: 73 KG