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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-22123-1A
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2020
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: used to complete insertion of the central line- two 12 fr guide wires kinked or bent while introducing wire. A third package was opened, this time an 8. 5 fr and the procedure was completed. (b)(4). A medwatch number is not documented on the user facility's medwatch report. Additional information: the risk manager reports that the patient had an iv in place upon admission to the er department. The risk manager reports that the device was not a factor in the patient's death. The patient was involved in a major vehicle accident and sustained multiple severe injuries. The patient arrived in the er department "coding". Note: additional mdr (9680794-2020-00067) will be submitted to reflect the second device with an alleged issue.
 
Event Description
According to the medwatch "during code trauma resuscitation a central line was being placed. During the process, three packages had to be opened to utilize a guide wire to facilitate placement of the central line. Guide wires kinked or bent during the placement, which would not allow the catheter to be passed over the wire. No injury to patient".
 
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Brand NameARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key9735329
MDR Text Key180305895
Report Number9680794-2020-00066
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue NumberCDC-22123-1A
Device Lot Number13F19H0118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2019
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: 02/20/2020 Patient Sequence Number: 1
Treatment
ARROWGARD BLUE PSI KIT CATH-GARD CDC-29803-1A WAS
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