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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 Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2023
Event Type  malfunction  
Event Description
It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
 
Manufacturer Narrative
Qn#(b)(4).Associated mdr#s: 3006425876-2023-00183; 3006425876-2023-00184; 3006425876-2023-00185; and 3006425876-2023-00186.
 
Event Description
It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
 
Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2023-00183; 3006425876-2023-00184; 3006425876-2023-00185; 3006425876-2023-00186; 3006425876-2023-00182.The customer returned one arrow raulerson syringe (ars) and introducer needle for analysis.Signs of use were observed on the returned components.Visual analysis of the introducer needle revealed a large lateral crack in the hub.The customer reported that a leak in the ars was observed, and upon failing functional testing, it was determined that the cracked needle hub likely caused or contributed to this defect.It was confirmed that the hub on the returned sample is the new hub design.The needle length measured 68mm, which is within the specifications of 67.49mm - 69.27mm per needle product drawing.The needle cannula outer diameter measured 0.04985" which is within the specifications of 0.0495"-0.0505" per the cannula product drawing.The needle cannula inner diameter measured 0.041", which is within the specifications of 0.041"-0.043" per the cannula product drawing.The needle and syringe were functionally tested per the instructions for use (ifu) provided with this kit, which states "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the syringe was not able to draw and aspirate water with the returned introducer needle.Water was observed to leak out of the crack in the needle hub.The crack in the needle hub of the returned needle likely caused or contributed to the observed leak.A device history record review was performed, and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The returned needle met all relevant dimensional requirements, and a device history record review was performed with no findings relevant to this investigation.The root cause of this complaint is design related.Teleflex has identified that the needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.Investigation of this issue is documented under a capa.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.".
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16305212
MDR Text Key309021091
Report Number3006425876-2023-00182
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K900263
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date02/17/2024
Device Catalogue NumberCS-27702-E
Device Lot Number71F22C0246
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2022
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
NOT REPORTED; NOT REPORTED
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