MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) FLEXTIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number	19 GAUGE CATHETER
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Epidural catheter fractured when being removed and required surgical intervention to remove retained catheter portion.Fda safety report id# (b)(4).

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETER
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); reading PA 19605
• MDR Report Key: 8531448
• Report Number: MW5085988
• Device Sequence Number: 16221289
• Product Code: CAZ
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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 Expiration Date: 10/31/2020
• Device Model Number: 19 GAUGE CATHETER
• Device Catalogue Number: AK 05502
• Device Lot Number: 23F19C0021
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 71