MAUDE Adverse Event Report: ARROW INTL., INC. ARROW CONTINUOUS NERVE BLOCK KIT

Catalog Number AB-05060-PK

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2014

Event Type  malfunction  

Event Description

The event was reported as: the clinician alleges that he was unable to view the tip of the catheter during the removal of the product.No report of pt injury or intervention.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• Brand Name: ARROW CONTINUOUS NERVE BLOCK KIT
• Type of Device: NERVE BLOCK KIT
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton, ra clinical speci ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3788791
• MDR Text Key: 4384855
• Report Number: 1036844-2014-00009
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-05060-PK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2014
• 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