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

Model Number	IPN046629
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was positioned to remove epidural catheter.Resistance was met.Patient repositioned, mild resistance met as catheter was removed, felt a snap and catheter came out without tip intact.

• Brand Name: ARROW
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 9309471
• Report Number: 9309471
• Device Sequence Number: 2373911
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019
• Report Date (Section F): 10/18/2019

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: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F19E0341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 117
• Date Report Sent to FDA: 10/18/2019