MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FLEX-TIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05502

Device Problems Difficult to Insert (1316); Defective Component (2292)

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

Event Date 03/29/2017

Event Type  malfunction  

Event Description

Provider noted difficulty with inserting needle for epidural block.Provider identified that the end of the needle was defective.Described as blunt with a burr on the end.

• Brand Name: ARROW FLEX-TIP PLUS EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill boulevard; morrisville NC 27560
• MDR Report Key: 6518718
• MDR Text Key: 73600350
• Report Number: 6518718
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2017,04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F16J0889
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 97