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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-15123-F
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Event Description
It was reported "in icu, the doctor found the swg kinked during used on the same patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported "in icu, the doctor found the swg kinked during used on the same patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).The customer returned one, opened, acute hemodialysis kit for analysis.The guide wire assembly will be analyzed as part of this complaint investigation.No definite signs of use were observed.Visual analysis did not reveal any defects or anomalies on the returned guide wire.Bending was noted on the outer tray; however, it is unknown if this occurred before or after the customer opened.The bending did not appear to affect the kit contents.The guide wire length measured 684mm, which is within the specification limits of 678mm-688mm per the guide wire product drawings.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawings.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of a kinked guide wire was not able to be confirmed through complaint investigation.The returned guide wire met all relevant visual and dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 12 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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19212034
MDR Text Key341370507
Report Number3006425876-2024-00403
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801902102164
UDI-Public00801902102164
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K970864
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,Followup
Report Date 04/01/2024
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 Catalogue NumberCS-15123-F
Device Lot Number71F21H0491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received05/16/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
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; NONE REPORTED
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