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 LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER INTRAVASCULAR THERAPE
  • 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 LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Model Number IPN916429
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem Insufficient Information (4580)
Event Date 01/18/2023
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).Associated mdr#s: 3006425876-2023-00148; 3006425876-2023-00262; 3006425876-2023-00174; 3006425876-2023-00176.
 
Event Description
It was reported "central end lumen of the cvc kinked - advancing wire and thus final insertion not possible." there was "delay in emergency use, loss of time".No patient information was available at the time of this report.
 
Event Description
It was reported "central end lumen of the cvc kinked - advancing wire and thus final insertion not possible." there was "delay in emergency use, loss of time".No patient information was available at the time of this report.
 
Manufacturer Narrative
(b)(4), associated mdr#s: 3006425876-2023-00148; 3006425876-2023-00262; 3006425876-2023-00174; 3006425876-2023-00175; 3006425876-2023-00176.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16452949
MDR Text Key310349049
Report Number3006425876-2023-00175
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN916429
Device Catalogue NumberCH-45854-USZ
Device Lot Number71F22E6106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
-
-