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

Catalog Number AB-19608-KS

Device Problem Component Missing (2306)

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

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Patient had catheter from femoral block in for almost 72 hours and upon attempted removal his wife, who is a nurse, noticed the coiled stimulating catheter tip was not there.An x-ray was done to confirm that no metal was left in the patient.No surgical intervention was necessary.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the stimucath with no relevant findings.A corrective action is not required at this time as the potential cause of a retracted catheter tip could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the stimucath catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a retracted catheter tip could not be determined based upon the information provided and without a sample.

Event Description

Alleged event: patient had catheter from femoral block in for almost 72 hours and upon attempted removal his wife, who is a nurse, noticed the coiled stimulating catheter tip was not there.An x-ray was done to confirm that no metal was left in the patient.No surgical intervention was necessary.The patient's condition was reported as fine.

• Brand Name: CONTINUOUS NERVE BLOCK KIT
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5444149
• MDR Text Key: 38995021
• Report Number: 1036844-2016-00084
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AB-19608-KS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention