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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-22123-F
Device Problems Difficult to Insert (1316); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
It was reported "catheter blockage cause difficult insertion". No patient harm reported. The device was replaced. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameARROW CVC SET: 3-LUMEN 12 FR X 16 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
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key12955117
MDR Text Key282283867
Report Number3006425876-2021-01123
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date04/07/2022
Device Catalogue NumberCS-22123-F
Device Lot Number71F20E1820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2020
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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