Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number ASK-17702-KR
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported that the user found the catheter leaking from a hole at around the 15cm mark on the catheter body.Therefore, the catheter was replaced with a new one.No patient harm was reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).
 
Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen cvc, a stopcock, and a lidstock for analysis.Signs of use in the form of biological material were observed inside the catheter body.After failing functional testing (see below), visual analysis revealed a small hole in the catheter body around the 15cm marking.Microscopic examination confirmed the damage and revealed that the appearance of the hole is consistent with damage due to contact a sharp instrument (i.E.Scalpel, scissors , etc.).The catheter body total length measured 217mm, which is within the specification of 210-227mm per catheter product drawing.The catheter body outer diameter measured 2.422mm, which is within the specification of 2.36mm-2.46mm per catheter extrusion product drawing.The cut on the catheter body measured 73 mm from the juncture hub.Functional inspection was performed on the returned catheter to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)".With the distal end of the catheter body occluded, both extension lines were flushed with a lab inventory arrow raulerson syringe (ars).When flushing the distal extension line, water was observed leaking at approximately the 15cm marking.The proximal extension line flushed as expected.A manual tug test confirmed the extension lines were fully secured within their respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The complaint of a catheter leaking was confirmed by a complaint investigation of the returned sample.Functional testing revealed a cut in the catheter body near 15cm marking.The cut was smooth, consistent with a sharp object contacting the catheter body.A device history record review was performed, and no relevant findings were found.Based on the sample returned, and the customer description that the damage was observed during use, unintentional use error (contact with sharps) , likely caused or contributed to this issue.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported that the user found the catheter leaking from a hole at around the 15cm mark on the catheter body.Therefore, the catheter was replaced with a new one.No patient harm was reported.The patient's condition is reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC KIT: 2-LUMEN 7FR X 20CM
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 Key16616613
MDR Text Key312310139
Report Number3006425876-2023-00274
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
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 03/01/2023
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 Expiration Date06/01/2024
Device Catalogue NumberASK-17702-KR
Device Lot Number71F22A1550
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/01/2023
Initial Date FDA Received03/25/2023
Supplement Dates Manufacturer Received04/20/2023
Supplement Dates FDA Received04/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2022
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
-
-