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

Catalog Number ASK-05502-FH1

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.

Event Description

It was reported that the user could not infuse through flextip plus catheter contained in the kit.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The reported complaint of the catheter would not infuse could not be confirmed based on the sample received.However, approximately 1cm of the proximal end of the catheter was received missing.The inner coils and extrusion showed no signs of stretching.The point of separation appears to be a clean break.The product ifu warns the user not alter the catheter or any other kit/set component during insertion, use, or removal.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test.However, based upon the condition of the sample received, operational context caused or contributed to this event.

Event Description

It was reported that the user could not infuse through flextip plus catheter contained in the kit.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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6263581
• MDR Text Key: 65266788
• Report Number: 1036844-2017-00019
• 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: 12/26/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05502-FH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2016
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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