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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 Unable to Obtain Readings (1516); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that "there was damping on the monitor within 6 hours of insertion. They did troubleshoot to see if it is the transducer. Once the catheter was removed, they saw it was kinked. ". A new a-line was inserted without incident.

 
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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 Key9659657
MDR Text Key177403239
Report Number3006425876-2020-00108
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK093050
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 01/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSAC-00520
Device LOT Number71F19F0473
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 Received02/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/19/2019
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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