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 HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA
  • 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 HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA Back to Search Results
Model Number IPN920484
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported: "after the device placement under fluoroscopy, while testing the two ends of the catheter, the one (blue) was working perfect while at the other tip (red), one could with extremely high pressure only insert saline." customer reported only the red extension line was not working properly after placement.The device was removed and "there is a big amount of clot blocking the one of the two end holes".Another device was placed.The patient's condition is reported as fine.
 
Event Description
It was reported: "after the device placement under fluoroscopy, while testing the two ends of the catheter, the one (blue) was working perfect while at the other tip (red), one could with extremely high pressure only insert saline." customer reported only the red extension line was not working properly after placement.The device was removed and "there is a big amount of clot blocking the one of the two end holes".Another device was placed.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned multiple components from a hemodialysis kit including a connector assembly, catheter body, two dilators, and sheath.Visual inspection of the connector assembly and catheter body did not reveal any defects or anomalies.The outer diameter of the arterial line measured 0.1880", which is within specifications of 0.185-0.191" per extrusion graphic.The inner diameter of the arterial line measured 0.123", which is within specifications of 0.120-0.126" per extrusion graphic.The connector assembly was functionally tested per the instructions for use (ifu) provided with this kit which states, "flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s)." both lines of the connector assembly were flushed with a lab inventory water filled syringe with not leaks or blocks detected.The ifu also states, "flush catheter thoroughly with sterile normal saline for injection to remove residual blood, post-treatment and before instilling heparin." the catheter body was assembled to the connector assembly and both lines were flushed again.No leaks or blocks were detected.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "open catheter clamp prior to infusion through lumen." the complaint of an extension line blocked was not able to be confirmed by a complaint investigation on the returned sample.The returned connector assembly and catheter body passed all relevant dimensional and functional testing.No blocks were able to be detected.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample returned, no problem was found on the device.Teleflex will continue to monitor and trend on complaints of this nature.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
Type of Device
CATHETER, HEMODIALYSIS, IMPLA
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16616621
MDR Text Key312311320
Report Number9680794-2023-00206
Device Sequence Number1
Product Code MSD
UDI-Device Identifier10801902195224
UDI-Public10801902195224
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K111117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN920484
Device Catalogue NumberCS-15272-X
Device Lot Number13F21L0628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2021
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
Patient Age80 YR
-
-