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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CA-27702
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the spring wire guide was kinked prior to patient use. No patient involvement.
 
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Brand NameARROW CVC KIT: 2-LUMEN 7 FR X 20 CM
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
MDR Report Key12583235
MDR Text Key274950544
Report Number9680794-2021-00496
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCA-27702
Device Lot Number13F21A0659
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
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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