MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; ECVC4300

Catalog Number ECVC4300

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient had a triple lumen catheter inserted for surgery on (b)(6) 2021.On (b)(6) 2021 the triple lumen catheter began leaking from the insertion site when flushed.Ultimately the patient had the triple lumen catheter removed and a peripherally inserted central catheter (picc) line was placed without further incident.The patient was discharged home with no follow up action needed.The sample was returned to the manufacturer for evaluation however the sample evaluation is pending at the time of this report.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be submitted.

Event Description

It was reported that the triple lumen catheter began leaking at the insertion site and required replacement.

Manufacturer Narrative

The sample evaluation was completed.A visual, functional and dimensional evaluation was performed and no leaks were noted.Based on the evaluation the customer reported issue was unable to be confirmed.A definitive root cause was not able to be determined at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be submitted.

• Type of Device: ECVC4300
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 3310 s main st; salisbury NC 28147
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13228106
• MDR Text Key: 290974022
• Report Number: 1038445-2022-00001
• Device Sequence Number: 1
• Product Code: OES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECVC4300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG