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; 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; CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-45703-P1A
Device Problems Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During the procedure the wire is too thin, it is kinking.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.It is unknown if therapy was delayed/interrupted.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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
During the procedure the wire is too thin, it is kinking.The reported defect was detected during use.The patient condition is reported as "fine".There was no patient complication, injury or consequence.It is unknown if therapy was delayed/interrupted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW MULTI-LUMEN PI CVC KIT
Type of Device
CATHETER INTRAVASCULAR THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10043457
MDR Text Key190511951
Report Number9680794-2020-00228
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,user f
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCDC-45703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-