MAUDE Adverse Event Report: CENTURION; VANTEX 7FR 3L 20CM CVC BUNDLE, CHOICE

Catalog Number ECVC8040B

Device Problem Obstruction of Flow (2423)

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

Event Date 11/08/2023

Event Type  Injury  

Event Description

According to the customer contact, "two of the ports to the patients ij unclamped with no lines running" and that "these lines became unclamped by themselves two more times during the night".

Manufacturer Narrative

According to the customer contact, "two of the ports to the patients ij unclamped with no lines running" and that "these lines became unclamped by themselves two more times during the night".The customer contact reported "one of the lines clogged and needed tpa instilled".The customer contact stated that there is no additional information available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: VANTEX 7FR 3L 20CM CVC BUNDLE, CHOICE
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 18818039
• MDR Text Key: 336738518
• Report Number: 3004519921-2024-00009
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ECVC8040B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other