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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN916469
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Event Description
It was reported that: "during insertion of the cvc, the distal extension line was defective.The line appeared to be blocked.It was impossible to inject anything.No clinical consequences but the device was changed".
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "during insertion of the cvc, the distal extension line was defective.The line appeared to be blocked.It was impossible to inject anything.No clinical consequences but the device was changed".
 
Manufacturer Narrative
(b)(4).The customer returned one 4-l catheter for analysis.Definite signs of use were observed within the catheter.Visual analysis revealed no obvious defects or anomalies with the returned catheter.The overall length of the catheter measured 169mm which is within the specification limits of 157-177mm per the catheter product drawing.The outer diameter of the catheter measured 2.958mm which is within the specification limits of 2.87-2.97mm per the extrusion product drawing.The outer diameter of the distal extension line measured 2.167mm which is within the specification limits of 2.13-2.21mm per the distal extension line product drawing.The inner diameter of the distal extension line measured 1.4732mm, which is within the specification limits of 1.42-1.50mm per the distal extension line product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which states , "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were flushed using a lab inventory syringe, and the lines flushed as intended.A lab inventory guide wire was also threaded through the distal lumen and passed with little to no resistance.No blockages were observed.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The catheter was connected to lab leak tester and pressurized to 300 kpa for 30 seconds.No leaks or blockages were observed from any region of the catheter.The ifu provided with this kit informs the user, "do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal.Ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the customer report of a blocked catheter could not be confirmed based on the investigation of the returned sample.The catheter and distal extension line passed all relevant visual, dimensional, and functional requirements and showed no evidence of a blockage or occlusion.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend on reports of this nature.
 
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Brand Name
ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
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
marling heaton
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19051131
MDR Text Key339558663
Report Number3006425876-2024-00295
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/05/2024
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 Model NumberIPN916469
Device Catalogue NumberFR-42854-IPSE
Device Lot Number71F23G0573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/05/2024
Supplement Dates Manufacturer Received04/11/2024
Supplement Dates FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2023
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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