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

Catalog Number AK-05502

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there were broken ampules when opening package.There was no injury.

Event Description

It was reported that there were broken ampules when opening package.There was no injury.

Manufacturer Narrative

(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated to address broken ampule issues for lot# 23f18k0548.The customer reported broken ampules in the kit.The customer returned one opened kit which contained the saline solution and lidocaine w/epinephrine ampules broken into two pieces for investigation.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 either ampules appear to be missing.No other defects or anomalies were observed.The reported complaint of broken ampules was confirmed based upon the sample received.The saline solution and lidocaine w/epinephrine ampules were found to have broken at the score line.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A nonconformance was initiated to further investigate this complaint issue.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8252794
• MDR Text Key: 133217010
• Report Number: 1036844-2019-00056
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F18K0548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1