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

Model Number 19 GAUGE CATHETER

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2019

Event Type  Injury  

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); reading PA 19605
• MDR Report Key: 8531448
• MDR Text Key: 142616935
• Report Number: MW5085988
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 71