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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
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional information requested, from customer, regarding clarity of the complaint description. No additional information received at the time of this report.

 
Event Description

The customer reports: when trying to break the equipment that was installed in the distal via, the tip of it is split staying within the catheter path and making it impossible to use.

 
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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 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 Key7292061
MDR Text Key100919315
Report Number9680794-2018-00047
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 DISTRIBUTOR,FOREIGN,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date02/29/2020
Device Catalogue NumberCV-17702
Device LOT Number14F16J0396
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 Received03/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2016
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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