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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR KIT: 20GA X 5" CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR KIT: 20GA X 5" CATHETER PERCUTANEOUS Back to Search Results
Catalog Number AK-04150-E-S
Device Problem Material Deformation (2976)
Patient Problems Death (1802); No Information (3190)
Event Date 07/17/2019
Event Type  Death  
Manufacturer Narrative

(b)(4). Customer contacted to obtain additional information regarding the event. No additional information received at the time of this report.

 
Event Description

It was reported that the catheter kinked during insertion by physician. Device was used in 3 different attempts and delayed case for patient. The reported defect was detected during use. There is a patient death reported. The customer was not clear if the reported issue caused/contributed/factored in the death of the patient. Therapy was reported to be delayed/interrupted.

 
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Brand NameARROW PEDIATRIC JUGULAR KIT: 20GA X 5"
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8950663
MDR Text Key156132557
Report Number9680794-2019-00343
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK810962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAK-04150-E-S
Device LOT Number13F19D0532
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2019
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: 08/30/2019 Patient Sequence Number: 1
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