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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-25703-E
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports the spring wire guide was kinked to cause a decrease in transfusions.

 
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Brand NameARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
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 Key8960028
MDR Text Key156451693
Report Number3006425876-2019-00646
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCS-25703-E
Device LOT Number71F19B2242
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2019
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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