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

Model Number	IPN045607
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Epidural catheter attempted to advance with placement, catheter did not thread and was withdrawn.The tip marker did not come back when catheter was removed.Less than 2mm of the tip of the epidural catheter was retained.Epidural catheter came from anesthesia kit.

• Brand Name: ARROW
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 8640127
• Report Number: 8640127
• Device Sequence Number: 13864049
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: (01)60801902005139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2019
• Report Date (Section F): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19A0550
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 05/14/2019