MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05560

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the staff opened the kit, the top of the lidocaine ampule had broken off.The contents of the kit had shifted and were scattered.There was no reported injury.

Manufacturer Narrative

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

Event Description

It was reported that when the staff opened the kit, the top of the lidocaine ampule had broken off.The contents of the kit had shifted and were scattered.There was no reported injury.

• Brand Name: SPINAL ANES/EPIDURAL CATH 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: 5987148
• MDR Text Key: 55930151
• Report Number: 1036844-2016-00504
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: AK-05560
• Device Lot Number: 23F16F0781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2016
• 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