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

Device Problems Defective Component (2292); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

An epidural catheter was placed for obstetrician (ob) anesthesia.Once in place, the anesthesiologist could not inject medication.The catheter was removed and found to be obstructed at the tip.This appears to be a manufacturing defect.

• Brand Name: ARROW FLEXTIP PLUS
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 4530680
• MDR Text Key: 5542192
• Report Number: 4530680
• 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

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2015
• Patient Sequence Number: 1
• Treatment: NO