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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-45703-P1A
Device Problem Material Separation (1562)
Patient Problem Death (1802)
Event Date 04/29/2020
Event Type  Death  
Manufacturer Narrative
(b)(4). Additional information received from user facility ((b)(6)) risk manager providing the following information: patient was coding at the time of the reported issue with the device. Upon removal of spring wire guide the device unraveled and/or separated. Device removed in its entirety and no retained device in patient. The assessment is made that the issue with the device was not a factor in the patient's death per information from risk manager.
 
Event Description
According to the medwatch "the guidewire broke as the md was withdrawing the central line. The distal port was clamped and capped. The 2 other ports drew easily and flushed without difficulty. Central line retrieved and appears to be whole. Central line insertion in a code blue patient".
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAP
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 Key10083316
MDR Text Key191958677
Report Number9680794-2020-00250
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/22/2020 Patient Sequence Number: 1
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