MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number	IPN033893
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient admitted to icu with 2/2 iv fluids running through cordis.Cordis placed in right femoral vein.Rn was attempting to draw lab work from cordis and only aspirated air.Question of cordis with hole or other equipment malfunction.Notified doctor and cordis was replaced over a guide wire.Notified supervisor.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 7348431
• Report Number: 7348431
• Device Sequence Number: 10958843
• Product Code: DYB
• UDI-Device Identifier: 00801902005519
• UDI-Public: (01)00801902005519
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2018
• Report Date (Section F): 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: IPN033893
• Device Catalogue Number: AK-09903-S
• Device Lot Number: 23R16D0616
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 110
• Date Report Sent to FDA: 03/14/2018