MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW; THERA CATHEPIDURAL CATHETER

Model Number EC-05000

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

Epidural catheter removed after vaginal delivery and bilateral tubal ligation procedure and spring wire tip not visible.Unable to tell if retracted into the sheath or broken off inside patient.

• Brand Name: ARROW
• Type of Device: THERA CATHEPIDURAL CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville rd.; reading PA 19605
• MDR Report Key: 4664975
• MDR Text Key: 5625252
• Report Number: MW5041913
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: EC-05000
• Device Catalogue Number: IC-05000-132A (5/10)
• Device Lot Number: 23F14C0458
• Other Device ID Number: (01)00801902009746
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 93