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

Catalog Number AK-05501

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2015

Event Type  No Answer Provided  

Event Description

A patient who orthopedic surgery took to the or for a right total knee arthroplasty; anesthesia was provided with an epidural catheter.Reportedly, during placement of epidural catheter, there were no complications.At the conclusion of the case, the above catheter was attempted to be withdrawn; however, it fractured with approximately five to six centimeters of retained material.Due to this, neurosurgery was consulted.

• Brand Name: EPIDURAL CATHETER WITH FLEX TIP PLUS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville rd; reading PA 19605
• MDR Report Key: 4534534
• MDR Text Key: 5514682
• Report Number: 4534534
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/05/2015

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?: No
• Device Operator: Physician
• Device Catalogue Number: AK-05501
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2015
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 96