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

Catalog Number AK-05502

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

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 have been around 5 kits that have shown up recently either with damage to the outer tray or the lid stock partially torn off, making product not sterile for use.

Event Description

It was reported that there have been around 5 kits that have shown up recently either with damage to the outer tray or the lid stock partially torn off, making product not sterile for use.

Manufacturer Narrative

(b)(4).A device history record review was performed on the outer tray and kit with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did provide photos that show the corner a kit having a crack.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the outer tray and kit with no evidence to suggest a manufacturing related cause.The customer did provide photos that show a kit with a crack in the outer tray.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9701953
• MDR Text Key: 179245661
• Report Number: 1036844-2020-00068
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19J0104
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1