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

Model Number	IPN036826
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Sterility issue: this morning in cardiac surgery anesthesiologist found a cordis with clearly foreign material at the entry valve.(was opened for use on the patient).Did not go into the patient.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 11245 n distribution cove; olive branch MS 38654
• MDR Report Key: 8163710
• Report Number: 8163710
• Device Sequence Number: 2118620
• Product Code: KGZ
• UDI-Device Identifier: 10801902117516
• UDI-Public: (01)10801902117516(17)190831(10)13F18G0758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2018
• Report Date (Section F): 11/30/2018

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: No Information
• Device Model Number: IPN036826
• Device Catalogue Number: AK-29903-CDC
• Device Lot Number: 13F18G0758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/30/2018