MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL

Lot Number 1905000066

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

The rn the was drawing blood off of umbilical arterial line.While the blood was flowing back into the syringe, the rn noticed very small drops of blood coming from the base of the catheter where it turns into the hub that connects to the arterial transducer.The catheter did not visibly look broken but when the blood was cleaned off, more would start to form around the outside of the catheter.The amount of blood loss was very minimal.The catheter where leak was occuring was covered with a tegaderm.Doctor was called and removed the catheter.A new catheter was placed.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9174900
• MDR Text Key: 161827329
• Report Number: 9174900
• Device Sequence Number: 1
• Product Code: FOS
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1905000066
• 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: 09/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 DA