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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP

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ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-45703-P1A
Device Problem Unraveled Material (1664)
Patient Problem Insufficient Information (4580)
Event Date 03/27/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reports issue with guidewire unraveling while pulling from the central line/introducer. There was no report of patient harm.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
Type of DeviceCATHETER INTRAVASCULAR THERAP
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 Key14197455
MDR Text Key290057397
Report Number9680794-2022-00250
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-45703-P1A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/24/2022
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

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