MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW FLEXTIP PLUS CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Model Number HS-05501

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/02/2020

Event Type  malfunction  

Event Description

Patient undergoing right total hip arthroplasty.At end of procedure, staff removed spinal epidural catheter and noticed that black tip was not visible.Patient underwent ct scan, catheter tip noted at l4- l5.Patient returned to operating room on (b)(6) 2020 for removal of catheter tip.Staff reported no unusual resistance when pulling catheter during initial procedure.

• Brand Name: ARROW FLEXTIP PLUS CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10128238
• MDR Text Key: 194703436
• Report Number: MW5094868
• 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
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HS-05501
• Device Catalogue Number: HS-05501
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 86 YR
• Patient Weight: 64