MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARRROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25142-F

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the dilator(large) splite" during use.No patient harm was reported.The device was replaced.The patient's condition is reported as fine.

Event Description

It was reported "the dilator(large) splite" during use.No patient harm was reported.The device was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the dilator(large) splite" during use.No patient harm was reported.The device was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one dilator for evaluation.Signs of use in the form of dried biological material were observed on the returned dilator.Visual inspection of the dilator revealed the tip was split and damaged.The tip also contained white coloration, indicating undue force was applied to the dilator tip during insertion.The total length of the dilator measured to be 5.47" which is within specifications of 5.25-5.75" per product drawing.This dilator contains a double-tapered design to aid in insertion.The outer diameter of the distal portion of the dilator measured to be 0.154" which is within specifications of 0.152-0.164" per product drawing.The outer diameter of the proximal portion of the dilator measured to be 0.184" which is within specifications of 0.183-0.186" per product drawing.The inner diameter of the distal tip could not be accurately measured due to the damage observed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the customer report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection confirmed the dilator tip was split and torn.The appearance of this damage is consistent with undue force being applied to the dilator during insertion.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARRROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15426945
• MDR Text Key: 305540943
• Report Number: 3006425876-2022-00793
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993933
• 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,Followup
• Report Date: 08/22/2022

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 Expiration Date: 06/15/2023
• Device Catalogue Number: CS-25142-F
• Device Lot Number: 71F22A2202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 10/07/2022; 12/14/2022
• Supplement Dates FDA Received: 10/10/2022; 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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