MAUDE Adverse Event Report: CENTURION MEDLINE; VANTEX 8.5F 20CM 4L CVC BUNDLE

Model Number	ECVC7785
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "the lines are brittle" and the lumens have a "bump around the orifice making them accumulate fibrin and requiring alteplase and repeat procedures".After numerous attempts, no additional information was provided in relation to the reported incident.The sample has been requested, but has not been returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility "the lines are brittle" and the lumens have a "bump around the orifice making them accumulate fibrin and requiring alteplase and repeat procedures".

• Brand Name: MEDLINE
• Common Device Name: VANTEX 8.5F 20CM 4L CVC BUNDLE
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16303342
• Report Number: 3004519921-2023-00003
• Device Sequence Number: 20377209
• Product Code: OES
• UDI-Device Identifier: 10653160349365
• UDI-Public: 10653160349365
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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 Model Number: ECVC7785
• Device Catalogue Number: ECVC7785
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown