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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-14402
Device Problem Complete Blockage (1094)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/22/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports: "during the passage of the bilumen catheter in patient. The distal lumen of the occluded catheter is sealed, catheter and defective guide".

 
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Brand NameARROW CVC SET: 2-LUMEN 4 FR X 13 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8817656
MDR Text Key151927082
Report Number9680794-2019-00261
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCS-14402
Device LOT Number14F18H0231
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/14/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2018
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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