• 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 2-L MAC KIT: 9 FR DISTAL X 4" (10 CM) 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 INC. ARROW 2-L MAC KIT: 9 FR DISTAL X 4" (10 CM) CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-21142-UCL1
Device Problems Break (1069); Material Separation (1562)
Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: product was inserted with no issues and patient went to 7 icu. Few days later rn removed the pa catheter. As it was being withdrawn the assembly around the "cortis" port broke loose and when removed the white area came loose, and the disc came out with the pa catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW 2-L MAC KIT: 9 FR DISTAL X 4" (10 CM)
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8889082
MDR Text Key154164051
Report Number1036844-2019-00903
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASK-21142-UCL1
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
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 Treatment Data
Date Received: 08/13/2019 Patient Sequence Number: 1
-
-