• 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 ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS

  • 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 ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00820
Device Problems Material Frayed (1262); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "difficulty to insert seldinger in a point of the arterial vessel without obstacles. Seldinger inserted to the second attempt by tilting the needle. At the moment to remove it the seldinger did not move. They removed it using a clamp and the outer terminal part appears frayed. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW ARTERIAL CATH SET: 20GA X 8CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key7846071
MDR Text Key119341845
Report Number3006425876-2018-00607
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSAC-00820
Device Lot Number71F17L1460
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-