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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-22702-E
Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported the physician found the guidewire body broken (kinked) during use. A new kit was opened to finish the procedure. No patient harm reported. The patient's condition is reported as fine.
 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 16 CM
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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 Key14738618
MDR Text Key295151100
Report Number3006425876-2022-00554
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
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 Initial,Followup
Report Date 05/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCS-22702-E
Device Lot Number71F21D1117
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
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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