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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDA-42703-P1A
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Event Description
It was reported the proximal port broke off of the triple lumen central line. The lumen was locked at the time of the incident. The device was removed and replaced on (b)(6) 2022. It was reported there was no patient injury and the patient's condition was fine. After catheter replacement the patient subsequently developed symptoms of fever, worsened tachycardia, increased vasopressor requirements overnight leading to blood cultures and regimen of antibiotics. It was unclear if the symptoms were related to catheter reinsertion. Additional information was requested but was not available at the time of this report.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
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
MDR Report Key14622747
MDR Text Key293526862
Report Number9680794-2022-00359
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDA-42703-P1A
Device Lot Number13F22A0958
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2022
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: 06/07/2022 Patient Sequence Number: 1
Treatment
NOT REPORTED
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