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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-27702-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4). No sample will be returned for evaluation.
 
Event Description
It was alleged that during insertion, resistance was met when inserting the guide wire resulting in the kinking of the wire. As a result, a new kit was opened and used without issue.
 
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Brand NameCVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
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
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5701031
MDR Text Key46613133
Report Number3006425876-2016-00162
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
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
Report Date 06/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2016
Device Catalogue NumberCS-27702-E
Device Lot Number23F14G0843
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 Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2014
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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