• 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 CVC SET: 14 GA X 6" (16 CM) 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 CVC SET: 14 GA X 6" (16 CM) CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04706
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2020
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4).

 
Event Description

It was reported that the logistics center found cracks on the edges of the tray.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW CVC SET: 14 GA X 6" (16 CM)
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 Key10546518
MDR Text Key207327763
Report Number3006425876-2020-00843
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK862056
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 09/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberES-04706
Device LOT Number71F19D2997
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-