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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); Material Twisted/Bent (2981)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2019
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. A new catheter 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 Key9376259
MDR Text Key179122308
Report Number3006425876-2019-00939
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 Received12/11/2019
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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