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 INC. ARROW VASCULAR UNKNOWN; CATHETER, HEMODIALYSIS,IMPLANT
  • 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 INC. ARROW VASCULAR UNKNOWN; CATHETER, HEMODIALYSIS,IMPLANT Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).Medwatch ((b)(4)).Customer contacted to obtain additional information.No response from customer at the time of this report.
 
Event Description
According to the medwatch (b)(4) "the patient came to the inu because her dialysis catheter was leaking from one of the ports.The patient was scheduled for a tunneled catheter exchange and when the catheter was removed from the patient, it was noted that the catheter was leaking from the venous port.It appears that the molding of the venous port where the plastic catheter goes into the white hub is where the defect in the catheter is.The catheter was exchanged with a new catheter, over a wire".
 
Manufacturer Narrative
Qn#(b)(4).Medwatch (b)(4).Additional information was received from the customer and it was reported that there was no harm to the patient.The customer returned one hemodialysis connector assembly for evaluation.The device contained signs of use in the form of biological material.After the connector assembly failed functional testing, it was microscopically examined.A small separation of the extension line was found near the juncture hub.The appearance of the damage is consistent with a continuous pulling force being placed in opposite directions on the juncture hub and extension line body.The connector assembly was functionally tested by plugging the distal end of the juncture hub and attaching a lab inventory syringe filled with water.When the plunger was depressed into both extension lines, water leaked out of the juncture hub area.A manual tug test confirmed the extension line body was secure within the luer hub.The standard ifu provided in hemodialysis kits cautions the user, "avoid excessive or prolonged use of alcohol-based solutions and ointments to clean catheter or site care." the ifu was also instructs the user to, "attach syringes to extension line hubs and open clamps.Blood should aspirate without difficulty from both extension lines." the customer report of an extension line leak was confirmed through complaint investigation.The venous extension line of the returned connector assembly was partially separated at the juncture hub, which allowed for leaking to occur.The appearance of the damage is consistent with a continuous pulling force being placed in opposite directions on the juncture hub and extension line body.The probable cause of the damage is likely unintentional user error.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
According to the medwatch (b)(4) "the patient came to the inu because her dialysis catheter was leaking from one of the ports.The patient was scheduled for a tunneled catheter exchange and when the catheter was removed from the patient, it was noted that the catheter was leaking from the venous port.It appears that the molding of the venous port where the plastic catheter goes into the white hub is where the defect in the catheter is.The catheter was exchanged with a new catheter, over a wire".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW VASCULAR UNKNOWN
Type of Device
CATHETER, HEMODIALYSIS,IMPLANT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8059397
MDR Text Key128658113
Report Number1036844-2018-00278
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/01/2018
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 No Information
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Initial Date Manufacturer Received 11/01/2018
Initial Date FDA Received11/12/2018
Supplement Dates Manufacturer Received12/14/2018
Supplement Dates FDA Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age30 YR
-
-