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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 20 GA X 8CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number SAC-00820-PBX
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). It is unknown if the device sample is available for evaluation.

 
Event Description

The customer reports that the catheter inserted radial or femoral does not work after a few hours. A blockage is reported. Impossible to do a pressure surveillance. A new catheter is required.

 
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Brand NameARROW ARTERIAL CATH. SET: 20 GA X 8CM
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 Key8860001
MDR Text Key153240291
Report Number3006425876-2019-00569
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK093050
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 07/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSAC-00820-PBX
Device LOT Number71F19F0648
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 Received09/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/05/2019 Patient Sequence Number: 1
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