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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CA-22703
Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During the procedure and after inserting the needle the guidewire was inserted but the doctor found the tip was stuck on the original sheathing and was difficult to advance. The doctor saw that the guidewire was bent in the middle. It looked like it had been bent in half as there was a visible kink in the middle of the wire. The patient condition is reported as "fine". There was no patient injury/consequence. Therapy was not delayed/interrupted.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8539783
MDR Text Key142766070
Report Number9680794-2019-00136
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberCA-22703
Device Lot Number13F18D0077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
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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