MAUDE Adverse Event Report: ARROW INTL., INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number WJ-05401

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges having difficulty passing the catheter through the hustead needle.The user alleges the inability to pass the catheter beyond the end of the touhy needle.The hustead needle was removed and an attempt was made to pass the catheter through the curve.The catheter was able to be passed through but with great difficulty.

Manufacturer Narrative

A device history record (dhr) review was performed on the epidural catheter and epidural needle and there were no issues found that could relate to the reported complaint.A review of change history data over the past two years was performed on the kit, the epidural catheter, and the epidural needle, with no material changes found that could have led to the reported complaint.Complaint verification testing could not be performed as no sample was returned for analysis.The device history records for the epidural catheter and the epidural needle were reviewed with no evidence to suggest a manufacturing related cause.The potential cause of difficulty threading the epidural catheter through the epidural needle could not be determined.If the sample is returned, a follow-up report will be submitted with investigation results.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTL., INC.; reading PA 19605
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3956972
• MDR Text Key: 4624359
• Report Number: 1036844-2014-00257
• 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: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WJ-05401
• Device Lot Number: 23F13L0480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1