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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-24703-E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "the luer hub (brown) was leaking" during use.No patient harm reported.The device was replaced.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one 3-l cvc catheter for analysis.Signs of use were observed within the extension lines and on the catheter body.Visual examination revealed that there was a hole in the distal extension line adjacent to the luer hub.The inner diameter of the distal lumen measured 1.4478 mm, which is within specifications of 1.42-1.50 mm per product drawing.The outer diameter of the distal lumen measured 2.187 mm which is within specifications of 2.13-2.21 mm per product drawing.This indicates that the wall thickness measured within specifications.The total length of the catheter body measured 325 mm), which is within specifications of 310-330 mm per catheter product drawing.The extension lines were functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal, medial, and proximal extension lines were flushed using a water-filled lab inventory syringe.When the distal line was flushed water, leaked through the hole adjacent to the luer hub.The medial and proximal extension lines flushed as intended.A manual tug test confirmed the distal, proximal, and medial extension lines were fully secured within the luer hubs.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk ofcutting or damaging the catheter or impeding catheter flow." the report of an extension line leak was confirmed through complaint investigation.Visual analysis revealed that the distal extension line had a hole adjacent to the luer hub.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The capa investigation indicated the root cause of this issue is manufacturing related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend complaints of this nature.
 
Event Description
It was reported "the luer hub (brown) was leaking" during use.No patient harm reported.The device was replaced.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 30 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 Key15139781
MDR Text Key303558451
Report Number3006425876-2022-00651
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
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 Other
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date08/23/2023
Device Catalogue NumberCS-24703-E
Device Lot Number71F21K0698
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2021
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
NOT REPORTED; NOT REPORTED
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