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

Catalog Number AK-05503

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/08/2019

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

The epidural tray contained broken vials.There was no injury.

Event Description

The epidural tray contained broken vials.There was no injury.

Manufacturer Narrative

(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural kit with no relevant findings.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 provided for analysis.A device history record review was performed on the epidural kit with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the broken ampules could not be determined based upon the information provided and without a sample.

Manufacturer Narrative

(b)(4).Method code: 3331, 4102.

Event Description

The epidural tray contained broken vials.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: 8281535
• MDR Text Key: 134329714
• Report Number: 1036844-2019-00035
• 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,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1