MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION SET; ANESTHESIA KIT

Catalog Number TU-05500-J

Device Problems Partial Blockage (1065); Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that when inserting the catheter into the epidural needle, the user could not insert/advance the catheter into the epidural needle.Another needle was used.

Manufacturer Narrative

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

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235947; zdar nad sazavou 0000
• Manufacturer Contact: margie burton ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3955730
• MDR Text Key: 15112034
• Report Number: 3006425876-2014-00124
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TU-05500-J
• Device Lot Number: 71F13M1100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1