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

Catalog Number SJ-05501

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

The customer alleges that the saline vial was broken upon opening of the kit.No patient/user injury.

Manufacturer Narrative

(b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation.A device history record review was performed on the kit and the saline ampule with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the kit and the saline ampule with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a broken ampule upon opening the kit could not be determined based upon the information provided and without a sample.

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL.INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4462792
• MDR Text Key: 5187574
• Report Number: 1036844-2015-00027
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F14J0409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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