MAUDE Adverse Event Report: TELEFLEX INC. / ARROW INTERNATIONAL, INC. ARROW; FLEX TIP PLUS EPIDURAL KIT

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Stenosis (2263)

Event Date 08/30/1988

Event Type  Injury  

Event Description

Epidural needle slightly bent after catheter placement.When catheter was discontinued, the tip was not intact and there was a hairline split at the catheter end.Ct on (b)(6) 2018 also revealed that pt had "advanced l5-s1 degenerative disc disease with chronic small right paracentral disc protrusion resulting in mid right canal stenosis and mild right lateral recess narrowing.".

• Brand Name: ARROW
• Type of Device: FLEX TIP PLUS EPIDURAL KIT
• Manufacturer (Section D): TELEFLEX INC. / ARROW INTERNATIONAL, INC.
• MDR Report Key: 7872565
• MDR Text Key: 120335681
• Report Number: MW5079773
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 3 MO