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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN918726
Device Problem Obstruction of Flow (2423)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 12/01/2023
Event Type  malfunction  
Event Description
It was reported "while using the device to infuse norepinephrine via the proximal line, it was observed that the side eyes along the catheter became blocked due to the formation of blood clots.This prevented the administration of norepinephrine".Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".Associated mdr number 3006425876-2024-00169.
 
Manufacturer Narrative
Qn#(b)(4).
 
Manufacturer Narrative
(b)(4).The customer returned one 4-l cvc for analysis.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed no obvious defects or anomalies.The catheter body length measured 167mm, which is within the specifications of 157-177mm per product drawing.The proximal extension line outer diameter measured 2.19mm which is within the specifications of 2.13-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4478mm, which is within the specifications of 1.42-1.50mm per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states , "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory 10ml syringe was used to flush all catheter lumens.Water was observed exiting the appropriate skive hole for all extension lines.No leaks or blockages were observed anywhere on the catheter body.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Visual inspection revealed no defects or anomalies.The returned catheter met all relevant dimensional and functional requirements, with no blockages found in the catheter during lab testing.A device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported "while using the device to infuse norepinephrine via the proximal line, it was observed that the side eyes along the catheter became blocked due to the formation of blood clots.This prevented the administration of norepinephrine".Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".Associated mdr number 3006425876-2024-00169.
 
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Brand Name
ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
Type of Device
CATHETER, PERCUTANEOUS
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 Key18767775
MDR Text Key336985567
Report Number3006425876-2024-00170
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN918726
Device Catalogue NumberCV-12854
Device Lot Number71F23C1189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received03/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2022
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.; NONE REPORTED.
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