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. CVC SET: 2-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS
  • 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. CVC SET: 2-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-27702-E
Device Problems Partial Blockage (1065); Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).No sample will be returned for evaluation.
 
Event Description
It was reported that the catheter lumen was blocked.This issue was reported through the taiwan adr with minimal information.The adr reports quarterly and as a result, no additional information will follow.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
ARROWG+ARD CATHETER PRODUCTS
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
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5812109
MDR Text Key50100822
Report Number3006425876-2016-00226
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCS-27702-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-