• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceARROWG+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 Key5481400
MDR Text Key39733249
Report Number1036844-2016-00146
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
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 Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F15G1368
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 Received02/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2016 Patient Sequence Number: 1
-
-