MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC

Model Number	IPN045729
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: the epidural was placed by certified registered nurse anesthetist (crna).Once the epidural catheter was in place, the catheter was not patent and unable to be flushed or have test dose administered.Connector changed by crna and there was still no success in flushing the epidural catheter.Epidural catheter was removed and there were no kinks or knots noted in the catheter.A new catheter was then placed and flushed successfully.The patient was not harmed and had a functional epidural on the second attempt.

• Brand Name: ARROW
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10173353
• Report Number: 10173353
• Device Sequence Number: 16887597
• Product Code: BSO
• UDI-Device Identifier: 10801902114430
• UDI-Public: (01)10801902114430(17)210531(10)23F20A0358
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/17/2020
• Report Date (Section F): 06/17/2020

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: Health Professional
• Device Model Number: IPN045729
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: 23F20A0358
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72
• Date Report Sent to FDA: 06/17/2020