MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15192-VFE

Device Problem Connection Problem (2900)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported "the tunneler can't be connected to the catheter tightly" during use on the patient.No patient harm reported.The p atient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the tunneler can't be connected to the catheter tightly" during use on the patient.No patient harm reported.The p atient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer provided one video showing the tunneling instrument and a portion of the catheter body.The video shows the customer inserting the tunneling instrument into the proximal end of the catheter body.An attempt to remove the tunneling instrument was then performed.It appears that moderate force was required to disconnect.The customer returned a tunneling instrument and the proximal end of the catheter body for analysis.Signs of use in the form of biological material was observed inside the catheter body.Microscopic examination of the proximal end of the catheter body revealed that the inner diameter was damaged/cracked.The appearance of the defect seems consistent with damage due to undue force.Per measurement d in the tunneling graphic, the outer diameter of the tunneling instrument at the distal tip measured.0765" which is within the specification limits of.0760"-.0780".Despite the damage, the inner diameter of the catheter body at the proximal tip measured.081" which is within the specification limits of.081"-.083" per the catheter connector graphic.The returned tunneling instrument was inserted into the proximal end of the catheter body.It was observed that components disconnected with moderate force.Performed per ifu statement "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp".The functionality of the tunneler/catheter connection was compared to a lab inventory tunneler/catheter assembly.It was noted that more force was required to separate the lab inventory assembly than the assembly involved with this complaint.The damage to the inside of the catheter likely contributed to this.R & d was contacted as part of this complaint investigation.They confirmed that when tested in accordance with annex b of bs en iso 10555-1, the force at break of the tunneler to catheter connection is >44.5 newtons.This indicates that the tunneler/catheter connection is meant to separate once a certain force threshold is reached.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated for material#/lot# c-70020-001/13c20d1444 to address the issue of a tunneler/catheter disconnect; however, upon analysis of the failure mode involved with this non-conformance, it was determined that the disconnect occurred due to the tunneling instrument being out of specification.As all dimensional requirements were met within this complaint, it has been determined that these two events are not related.The ifu provided with the kit informs the user, "do not forcefully pull tunneler and catheter apart; catheter breakage may occur".The report of a tunneler/catheter disconnect was confirmed through complaint investigation.Visual and functional analysis revealed that the tunneling instrument could be removed from the catheter body with moderate force and less force was required when compared to lab inventory components.Damage was observed to the inner diameter of the catheter body which likely contributed to the disconnection issues.The appearance of the damage is consistent with undue force or repeated manual disconnections.Despite the damage, all relevant dimensional requirements were met, including the tunneler outer diameter.Based on the customer report, the sample received, and the comments from r & d, the root cause for this issue is unintentional use error.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• 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 Key: 14836419
• MDR Text Key: 295967177
• Report Number: 9680794-2022-00400
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F21L0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1