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 11/30/2018

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 2 trays have broken vials of lidocaine and saline in them.There was no injury.

Manufacturer Narrative

Qn# (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# 23f18k0547.Complaint verification testing could not be performed as no sample was returned for analysis.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.

Event Description

It was reported that 2 trays have broken vials of lidocaine and saline in them.There was no injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8253090
• MDR Text Key: 133226674
• Report Number: 1036844-2019-00057
• 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: 11/30/2018

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: 23F18K0547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1