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

Catalog Number CS-15242-SP

Device Problem Connection Problem (2900)

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

Event Date 06/22/2022

Event Type  malfunction  

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 was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one tunneling instrument and one hemodialysis catheter body for evaluation.Signs of use in the form of biological material were noted on the catheter body.Visual inspection did not reveal any defects or anomalies on either component returned.The inner diameter of the red catheter connector measured 0.110" which is within specifications of 0.109-0.111" per catheter connector graphic.The outer diameter of the distal end of the tunneling instrument measured 0.07700" , which is within specifications of 0.076-0.078" per tunneling instrument graphic.The outer diameter of the narrow section of the tunneling instrument (dim e) measured 0.0625" , which is within specifications of 0.061-0.063" per tunneling instrument graphic.The returned tunneling instrument and catheter body were functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "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 tunneler tip was able to be snapped into the red catheter connector with no issues.Moderate force was required to remove.A device history record review was performed and one finding was identified.A non conformance was initiated for 13c20b1538 in regards to catheter tight in sheath; this is not relevant to this complaint investigation.The complaint of a loose connection between the catheter connector and tunneling instrument was not able to be confirmed by complaint investigation of the returned sample.Both the tunneling instrument and the catheter passed all relevant dimensional and functional testing.A device history record review was performed, and no relevant findings were identified.Based on the sample returned, no problem was found on the device.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

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

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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 Key: 15020928
• MDR Text Key: 302928095
• Report Number: 9680794-2022-00426
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: CS-15242-SP
• Device Lot Number: 13F20G0449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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