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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number EDC-00818
Device Problem Material Twisted/Bent (2981)
Patient Problems Pain (1994); Swelling (2091); No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer reports that upon removal the catheter was curled/kinked. It is unknown if the device was positioned and secured properly. No report that infusion/flow was obstructed.
 
Event Description
Catheter was placed in the upper arm on (b)(6) 2019, on (b)(6) 2019 the site was swollen and sore, catheter was removed and found to be curled/kinked.
 
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Brand NameARROW EXT DWELL CATH DEVICE 18GAX8CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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 Key8955857
MDR Text Key156485646
Report Number9680794-2019-00331
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEDC-00818
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Yes
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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