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

Catalog Number SJ-05501

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The report states that the doctor could not inject through it even after it was removed from the patient, so another kit was opened to do it again.There was no patient injury.

Manufacturer Narrative

(b)(4).The customer reported the catheter would not inject.The customer returned one snaplock adapter, one epidural catheter, and lidstock.The snaplock adapter and catheter were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive can be seen on the outer extrusion and biological material can be seen within the inner coils of the catheter especially at the distal end of the catheter.A manual flow test was performed using the returned components.An attempt was made to thread a laboratory inventory wire through the epidural catheter from the proximal end until an occlusion was found.Other remarks: microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils.A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the condition of the sample received and the information provided indicates that operational context caused or contributed to this event.The reported complaint of catheter not being able to inject was confirmed based on the sample received.The returned epidural catheter was found to be completely occluded with biological material.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils at approximately 10.3cm from the distal tip.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based on the condition of the sample received and the information provided, operational context caused or contributed to this event.Teleflex will continue to monitor and trend related events.

Event Description

The report states that the doctor could not inject through it even after it was removed from the patient, so another kit was opened to do it again.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 6875811
• MDR Text Key: 86611183
• Report Number: 1036844-2017-00349
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F17D0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2017
• 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