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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-24301-E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the catheter was found leaking during patient use. No patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW CVC SET: 16 GA X 8" (20 CM)
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key13764412
MDR Text Key287248966
Report Number3006425876-2022-00216
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 Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Followup
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCS-24301-E
Device Lot Number71F21D1118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
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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