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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-27702-E
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
According to the pcf the md was performing the procedure according to ifu. During insertion, tip of the swg (spring wire guide) was bent and could not pass anymore. The md was unable to proceed with the product and used new product.
 
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Brand NameARROW CVC SET: 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 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 Key10245650
MDR Text Key197971494
Report Number3006425876-2020-00589
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCS-27702-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
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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