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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-25703-E
Device Problem Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/08/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). It was reported the patient died from "covid diagnostic".
 
Event Description
It was reported when the doctor tried to remove the spring wire guide, the guide got stuck in the patient's skin. The guidewire was "removed by phlebography and the strange element (guidewire) extraction".
 
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Brand NameARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
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
MDR Report Key12598673
MDR Text Key275423880
Report Number3006425876-2021-00920
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeEC
PMA/PMN Number
K900263
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 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCV-25703-E
Device Lot Number71F20E1775
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
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