MAUDE Adverse Event Report: CENTURION; CENTRAL LINE BUNDLE

Catalog Number	ECVC6730B
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	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 3/19/2024, "the guidewire went in while starting a left ij.It went in initially without difficulty but then it had trouble advancing.The patient had a tunneled dialysis in the right subclavian so they had to use the left.Lost access but then reestablished access.The wire advanced and was in place.Inserted the triple lumen but couldn't remove the wire.So put the needle back on by ultrasound guidance.We could see something was wrong with the tip and was able to dislodge from the vessel wall by us guidance".The customer reported that" the provider opened a new kit and placed the central line without issue" and that the "patient is doing as expected".The customer reported that a sample is available for evaluation.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.
Event or Problem Description
According to the customer on 3/19/2024, "the guidewire went in while starting a left ij.It went in initially without difficulty but then it had trouble advancing.

• Common Device Name: CENTRAL LINE BUNDLE
• 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: 19123983
• Report Number: 3004519921-2024-00025
• Device Sequence Number: 8230334
• Product Code: LRO
• UDI-Device Identifier: 00653160352146
• UDI-Public: 653160352146
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/17/2024

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: ECVC6730B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown