MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH CONTINUOUS NERVE BLOCK SET; ANESTHESIA CONDUCT KIT

Catalog Number AB-19608-S

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the catheter frayed at the connector, such that the metal coil was separated from the outer white plastic layer.There was no reported patient injury.

Manufacturer Narrative

(b)(4).Report 3006425876-2019-00208 is retracted as the additional information indicates no potential patient injury or need for catheter replacement.

• Brand Name: STIMUCATH CONTINUOUS NERVE BLOCK SET
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8417267
• MDR Text Key: 138690337
• Report Number: 3006425876-2019-00208
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K030937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-19608-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1