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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the blue part of cvc leak with fracture. ".
 
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Brand NameARROW CVC SET: 2-LUMEN 8 FR X 20 CM
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 Key8596951
MDR Text Key144671590
Report Number3006425876-2019-00358
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? Yes
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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