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

Catalog Number AK-05503

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

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 they had 3 wet taps due to the catheter and the catheter feels stiffer.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.The customer reported recently three "wet taps" have occurred during insertion of the epidural catheter due to the catheter feeling stiffer.The puncture of the dura or a wet tap is typically a function of the user and is not necessarily a defective component.However, if a component would be involved in the cause it would be the epidural needle which was not returned for evaluation.Therefore, the ifu for this product, (b)(4), was reviewed as a part of this complaint investigation.The ifu for this product warns the user, "remove needle and attempt new puncture when blood or spinal fluid is returned in plunger barrel.The needle has been placed incorrectly".A review of design change history for part numbers kz-05400-002 and ebz-05400-003 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.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.Other remarks: complaint verification testing could not be performed as no sample was returned for analysis.Typically, a dura puncture or wet tap is a function of the user and is not a function of a defective epidural needle component.A device history record review was performed on the catheter and needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.

Event Description

The report states that they had 3 wet taps due to the catheter and the catheter feels stiffer.The patient's condition was reported as fine.

• 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: 6573063
• MDR Text Key: 75416415
• Report Number: 1036844-2017-00201
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F16L0698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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