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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 20 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-27702-E
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4) the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection r revealed a slight bend towards the distal end.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opend up the new kit to finish the procedure." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".The returned device was found to be kinked.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
CATHETER 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
elaine cully
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19200510
MDR Text Key341357319
Report Number3006425876-2024-00459
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801902102362
UDI-Public00801902102362
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,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue NumberCS-27702-E
Device Lot Number71F22D1272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2024
Initial Date Manufacturer Received 04/18/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED
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