MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT

Model Number IPN038423

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  malfunction  

Event Description

A patient was admitted for labor and delivery. The anesthesia provider tried to place an epidural catheter. Minimal resistance was met. After loss of resistance, the catheter failed to thread, and the needle was removed. At that time, it was noted that the tip of the tuohy needle was bent forward, partially occluding the orifice. It is uncertain whether the tip was bent prior to insertion or during placement. There is concern that the tip should not bend and can create a safety issue as it can shear the catheter upon threading. A similar event reportedly occurred with a different patient in the cardiac operating room (o. R. ) recently. We are unsure if there is an issue with this lot. The patient required general anesthesia for a c-section.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 50 plantation drive; jaffrey NH 03452
• MDR Report Key: 8568906
• MDR Text Key: 143712603
• Report Number: 8568906
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IPN038423
• Device Catalogue Number: ASK-05500-JHH1
• Device Lot Number: 23F18J0108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage