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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 Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The customer reports: upon initial insertion, md was checking patency of the line via the three ports. One of the ports drew air while attempting to aspirate blood. The other two ports did not draw air while aspirating blood.
 
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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 Key8153002
MDR Text Key130028070
Report Number1036844-2018-00308
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F17C0649
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2017
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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