MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15242-VSP

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "after the catheter is positioned, the tunnel needle cannot be tightly connected to the catheter connection end (red buckle)".The user had to use "surgical forceps to pass through the tunnel under the skin, and then clamp the tip of the catheter, pulled out the catheter from the tunnel with force" which leads to "serious tunnel tear and crack" under the skin of the patients and "prolongs the operation time".No patient injury or complication reported.It was reported the patient is "in good condition and not harmed".

Manufacturer Narrative

(b)(4).The customer supplied a video showing the reported defect of the tunneling instrument and catheter disconnection issue.The video shows that the catheter and tunneler are easily disconnected.The customer returned the proximal end of the catheter body for analysis.The tunneling instrument was not returned.Signs-of-use in the form of biological material was observed on the catheter body.Visual analysis did not reveal any defects or anomalies of any kind on the catheter body.Visual analysis could not be performed on the tunneling device as it was not returned for analysis.The inner diameter of the catheter body measured.081", which is within the specification limits of.081"-.083".A lab inventory tunneler with the same dimensions as the tunneler normally packaged within the finished kit was inserted into the proximal end of the catheter body.The tunneler was able to successfully lock onto the catheter body and was not able to be removed.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit provides the following warnings, cautions and instructions for the user: "do not tunnel through muscle." "do not forcefully pull tunneler and catheter apart; catheter breakage may occur." "do not pull tunneler out of the venous insertion site on an angle; pull parallel to the body." "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp." "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark." the report of a tunneler/catheter disconnecting was confirmed through examination of the customer supplied video.Visual analysis revealed that the tunneler could be easily removed from the catheter; however, as the tunneler was not returned for analysis, the failure mode cannot be officially confirmed.Despite this, the catheter body met all relevant dimensional and functional requirements, and a device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined without the tunneler to analyze.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "after the catheter is positioned, the tunnel needle cannot be tightly connected to the catheter connection end (red buckle)." the user had to use "surgical forceps to pass through the tunnel under the skin, and then clamp the tip of the catheter, pulled out the catheter from the tunnel with force" which leads to "serious tunnel tear and crack" under the skin of the patients and "prolongs the operation time." no patient injury or complication reported.It was reported the patient is "in good condition and not harmed.".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11292436
• MDR Text Key: 230689375
• Report Number: 9680794-2021-00038
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 13F20F0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1