MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05400-BW

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The saline in the kit is not protected and it is broken upon opening the kit.There was no reported injury.

Manufacturer Narrative

(b)(4).No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on epidural kit and saline ampule with a relevant finding.The digital master sample kit does not depict placement of the saline ampule in the protective sleeve.(b)(4) were reviewed as a part of this complaint investigation.A potentially relevant finding was discovered during a device history record review on the epidural kit.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.Complaint verification testing could not be performed as no sample was returned for analysis.No lot number was provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review performed on the epidural kit indicated a potential relevant finding that may have contributed this complaint issue.The digital master sample kit does not depict placement of the saline ampule in the protective sleeve.Although, a sample was not returned, based on the dhr review, the potential root cause of this complaint issue is design other remarks: related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.

Event Description

The saline in the kit it is not protected and it is broken upon opening the kit.There was no reported injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA X 35
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5950345
• MDR Text Key: 54697928
• Report Number: 1036844-2016-00495
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05400-BW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1