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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-25703
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
When passing the central venous catheter, the guide advances in a normal way, when passing the dilator, it folds the guide, being trapped, damaging the guide and preventing the catheter from advancing. This case is presented twice in the same patient with a product of the same reference and the same batch.
 
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Brand NameARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
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
9194334854
MDR Report Key8350087
MDR Text Key136518709
Report Number3006425876-2019-00137
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/03/2020
Device Catalogue NumberCV-25703
Device Lot Number71F18C1409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2018
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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