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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAP
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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDA-45703-P1A
Device Problems Material Frayed (1262); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: during the installation, there was difficulty in removing thee guide, and it was removed together with the catheter, it came out frayed. Another device was used without incident.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAP
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 Key8408022
MDR Text Key138387644
Report Number9680794-2019-00071
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberCDA-45703-P1A
Device Lot Number13R17E9095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2017
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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