MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problem Kinked (1339)

Patient Problem Death (1802)

Event Date 01/28/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).This report is for the thrid in a series consecutive product issues with the same patient.The first two events were reported under mdr#s 1036844-2016-00144 and 1036844-2016-00145.No sample will be returned for evaluaiton for this event.

Event Description

It was reported the catheter was being placed into a patient during a code situation.When trying to gain access the guide wire kinked.The patient expired.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5481400
• MDR Text Key: 39733249
• Report Number: 1036844-2016-00146
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15G1368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR