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

Catalog Number	ECVC6120
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 a "right subclavian central line" was attempted when the needle "would not draw".The customer reported after the incident occurred the "subclavian approach was abandoned" and a "right ij approach" was attempted with a "new kit".The customer did not report any serious injury, medical intervention, or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 (b)(6) 2024 a "right subclavian central line" was attempted when the needle "would not draw".

• Common Device Name: CVC BUNDLE VANTEX 7FR, 20CM, 3L
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19481342
• Report Number: 3004519921-2024-00029
• Device Sequence Number: 8047812
• Product Code: LRO
• UDI-Device Identifier: 00653160363753
• UDI-Public: 00653160363753
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ECVC6120
• Device Lot Number: 2024021590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 118 KG