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

Catalog Number SJ-05501

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.

Manufacturer Narrative

(b)(4). No lot number was provided. A device history record review was performed based upon a lot number from sales history data. 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. No lot number was provided. A device history record review was performed based upon a lot number from sales history data. The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.

Event Description

It was reported that there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7703888
• MDR Text Key: 114546191
• Report Number: 1036844-2018-00206
• 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

• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage