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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 8" CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 16 GA X 8" CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CA-24301
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported the packaging was damaged. The device was not used on the patient.
 
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Brand NameARROW CVC KIT: 16 GA X 8"
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
MDR Report Key11177182
MDR Text Key227027316
Report Number9680794-2021-00031
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberCA-24301
Device Lot Number13F19H0373
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2019
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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