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

Catalog Number CK-05401

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2016

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

Broken vials were in the kit.There was no reported injury.

Manufacturer Narrative

(b)(4).A device history record review was performed on the kit and the ampules with no relevant findings.The customer reported broken ampules in the kit.The customer returned one opened kit which contained a saline solution ampule broken into two pieces for investigation (reference attached files (b)(4)).The ampule was visually examined with and without magnification.Visual examination of the ampule revealed the ampule is broken at the score line.No pieces of the ampule appear to be missing.No other defects or anomalies were observed (reference files (b)(4)).A corrective action is not required at this time as it cannot be determined at what point the saline ampule broke.However, shipping and handling could not be eliminated as potential causes.The reported complaint of a broken ampule was confirmed based upon the sample received.The saline ampule was found to have broken at the score line.No pieces of the ampule were missing.A device history record review was performed on the kit and the ampules with no evidence to suggest a other remarks: manufacturing related cause.Therefore, the potential cause of a broken ampule could not be determined.However, shipping and handling could not be eliminated as potential causes.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

Broken vials were in the kit.There was no reported injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• 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: 6107172
• MDR Text Key: 60074695
• Report Number: 1036844-2016-00575
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: CK-05401
• Device Lot Number: 23F16F0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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