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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-42703-P1A
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 12/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Information obtained from maude report (mw5082351/mdr report key (b)(4)). The report does not have any additional information or contact information.
 
Event Description
According to the maude report (mw5082351/mdr report key (b)(4)), the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced. A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027). The wire in the second kit was stripped. Both kits were unusable. A different product was used successfully.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
Type of DeviceCATHETER INTRAVASCULAR THERAP
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 Key8281357
MDR Text Key134472125
Report Number9680794-2019-00026
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberCDC-42703-P1A
Device Lot Number13F18D0506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2018
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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