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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 PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-17702-BZ
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/03/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A dhr was performed and there no relevant findings.

 
Event Description

The customer reports: the catheter was folding easily and was blocking the flow.

 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8641076
MDR Text Key146086910
Report Number9680794-2019-00195
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCV-17702-BZ
Device LOT Number14F18F0465
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2018
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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