Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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"; 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"; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CDC-45703-P1A
Device Problems Difficult to Remove (1528); Sticking (1597); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Spring wire guide/catheter resistance - spring wire guide separation/break documented in mdr #3003737899-2018-00025.
 
Event Description
The customer alleges the doctor had a little difficulty inserting the guide wire but could insert.Once the guide wire was placed, the doctor used an expander and then threads the catheter over the guide wire.Upon removal of the guide wire, it is reported that it got stuck and very difficult to pull out.A lot of force and hemostats were used and the guide wire began to unravel and break as the doctor pulls out the guide wire.The entire catheter and guide were removed from the patient and the procedure restarted with a new central line kit.No patient injury or delay in treatment reported.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer alleges the doctor had a little difficulty inserting the guide wire but could insert.Once the guide wire was placed, the doctor used an expander and then threads the catheter over the guide wire.Upon removal of the guide wire, it is reported that it got stuck and very difficult to pull out.A lot of force and hemostats were used and the guide wire began to unravel and break as the doctor pulls out the guide wire.The entire catheter and guide were removed from the patient and the procedure restarted with a new central line kit.No patient injury or delay in treatment reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7320554
MDR Text Key101968246
Report Number3003737899-2018-00024
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue NumberCDC-45703-P1A
Device Lot Number13F17J0451
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-