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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25123-F
Device Problem Material Deformation (2976)
Patient Problem Death (1802)
Event Date 12/07/2019
Event Type  Death  
Manufacturer Narrative
(b)(4). The patient is deceased. Cause of death is currently unknown. Additional information requested regarding this event. No additional information received at the time of this report.
 
Event Description
The customer reports that the doctor inserted the guidewire through the dilator and exerted some pressure on the dilator and the guidewire kinked.
 
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Brand NameARROW CVC KIT: 3-LUMEN 12 FR X 20 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
colonia panamericana, chihuahua
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9580967
MDR Text Key174700814
Report Number9680794-2020-00044
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSF
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,Followup,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Catalogue NumberCS-25123-F
Device Lot Number71F19C2232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/13/2020 Patient Sequence Number: 1
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