MAUDE Adverse Event Report: ARROW INTERNATIONAL INC ARROW EPIDURAL CATHETERIZATION SET

Catalog Number JC-05400-B

Device Problem Fitting Problem (2183)

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

Event Date 04/25/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that there is a defect in the syringe/tuohy needle connection.

Manufacturer Narrative

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

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Manufacturer (Section D): ARROW INTERNATIONAL INC; reading PA 19605
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 235947
• Manufacturer Contact: margie burton, rn, reg affairs ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3915390
• MDR Text Key: 4489046
• Report Number: 3006425876-2014-00114
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F1481051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1