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

Catalog Number AB-19608-S

Device Problem Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.

Event Description

The customer alleges that the catheter gets stuck in the patient.No report of a patient injury.

Manufacturer Narrative

(b)(4).The lot number was not provided by the customer; therefore, the device history record (dhr) review was performed based upon a lot number from sales history of the customer.There were no relevant findings.The ifu for this product was reviewed as a part of the complaint investigation.The ifu contains a catheter removal procedure and warns the user, "catheters advanced too far may have entangled with some nerves or nerve roots." the ifu instructs the user "remove catheter by placing patient in same position that was used to insert catheter.If resistance is encountered, stop; reposition patient and attempt removal again.Pressure on skin in the opposite direction from direction catheter is being pulled often helps to facilitate removal." complaint verification testing could not be performed as no sample was returned for analysis.A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause.The potential cause of difficulty removing the catheter could not be determined based upon the information provided and without a sample.

Event Description

The customer alleges that the catheter gets stuck in the patient.No report of a patient injury.

• Brand Name: ARROW CONTINUOUS NERVE BLOCK SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5403943
• MDR Text Key: 37337707
• Report Number: 1036844-2016-00046
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-19608-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1