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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00520
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that after 24-48 hours, the catheter must be substituted because it kinks and it is not possible detect pressure values or make blood samples. It's reported that no medical intervention was required.

 
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Brand NameARROW ARTERIAL CATH SET: 20GA X 5CM
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 Key8148180
MDR Text Key129897883
Report Number3006425876-2018-00783
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
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 11/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSAC-00520
Device LOT Number71F18J1377
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/20/2018
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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