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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CV-47702-E
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The customer reports: the guide wire does not advance. The guide wire was kinked.
 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 2
colonia panamericana, chihuahua
chihuahua NC 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8447613
MDR Text Key139681853
Report Number1036844-2019-00299
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberCV-47702-E
Device Lot Number23F18E0016
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 Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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