MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA COVIDIEN UMBILICAL VESSEL CATHETER; CATHETER, UMBILICAL ARTERY

Model Number ARGYLE POLYURETHANE

Device Problems Difficult to Flush (1251); Moisture Damage (1405); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  Injury  

Event Description

Uac bp waveform noted to be dampened, attempted to flush line and pull back and it was noted to be very difficult to flush / pullback blood.Iv fluids and transducer replaced by this rn.Line with no change in status.Umbilical line removed by neonatologist.Catheter appeared to have a small hole near tip of catheter.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN UMBILICAL VESSEL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA
• MDR Report Key: 9632291
• MDR Text Key: 176575478
• Report Number: MW5092509
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: ARGYLE POLYURETHANE
• Device Catalogue Number: 3.5 FR
• Device Lot Number: 1904300070
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR