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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04301
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4).

 
Event Description

The customer reports that the guide wire bent during the puncture. The guide wire was difficult to advance. This issue brought pain to the patient. The guide wire and needle were immediately pulled, pressure applied to the site and a new device was successfully inserted.

 
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Brand NameARROW CVC SET: 16 GA X 8" (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 Key9376242
MDR Text Key179122908
Report Number3006425876-2019-00938
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberES-04301
Device LOT Number71F16D1607
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2016
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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