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

Catalog Number EJ-05400-E

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that when removing the catheter to exchange with a new catheter, the catheter was separated at 3 or 4 cm from the tip.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete 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 19605
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 2359/47
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3868892
• MDR Text Key: 15113054
• Report Number: 3006425876-2014-00095
• Device Sequence Number: 1
• Product Code: CAZ
• 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: Physician
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: ZF3037559
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1