• 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. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP

  • 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. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP Back to Search Results
Model Number IPN036438
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Hematoma (1884)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: during insertion, the wire was unable to thread through the catheter. The user tested it initially and it was "a bit sticky" but the user tried to dilate the catheter by sliding the wire through twice. This helped a little however the user was unable to withdraw the wire through the catheter once it was placed. The catheter and wire were removed together and another catheter was placed on the opposite side. The device did not cause injury or death, but it was reported the patient had a hematoma. The patient's condition was reported as "guarded".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
Type of DeviceCATHETER INTRAVASCULAR THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key11622311
MDR Text Key248233330
Report Number9680794-2021-00144
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN036438
Device Catalogue NumberCDC-45703-P1A
Device Lot Number13F20M0394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-