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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. UNKNOWN - ARTERIAL CATHETER CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. UNKNOWN - ARTERIAL CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problems Unable to Obtain Readings (1516); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports that the arterial catheter kinked. No measurement of arterial pressure was possible via the arterial catheter. The catheter was removed.

 
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Brand NameUNKNOWN - ARTERIAL CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9539970
MDR Text Key173537076
Report Number1036844-2020-00009
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
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 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVASCULAR UNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? Yes
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: 01/02/2020 Patient Sequence Number: 1
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