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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 THERAPE

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the wires have been kinking and difficult to thread. The patient's condition is reported as fine.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8339738
MDR Text Key136158302
Report Number1036844-2019-00125
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F18E0147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2018
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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