MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION MULTI-MED; CENTRAL VENOUS CATHETER KIT

Model Number	ECVC2240
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While placing a cvc in the right subclavian, the guidewire came apart.Doctor tried to remove the guidewire out of soft tissue, this was unsuccessful.Patient was then prepped and an incision was made to remove the wire.

• Brand Name: CENTURION MULTI-MED
• Common Device Name: CENTRAL VENOUS CATHETER KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 3310 s main st.; salisbury NC 28147
• MDR Report Key: 6858797
• Report Number: 1038445-2017-00001
• Device Sequence Number: 706240
• Product Code: OES
• UDI-Device Identifier: 10653160258803
• UDI-Public: (01)10653160258803(10)2017010950(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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 Expiration Date: 10/31/2018
• Device Model Number: ECVC2240
• Device Lot Number: 2017010950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/12/2017
• 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: Required Intervention