MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: it was reported that, when the user checked the catheter with x-ray after placement, it was found kinked.According to the user, there seemed to be no problem with blood flow in the catheter, so he/she continued to use it as it was.It occurred to two catheters.Additional information: the kink in the catheter did not affect the treatment.The catheter was kinked 23cm from the tip.It was inserted in the right jugular vein.The catheter could be flushed without issue.No injury to the patient was reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

It was reported that: when the user checked the catheter with x-ray after placement, it was found kinked.According to the user, there seemed to be no problem with blood flow in the catheter, so he/she continued to use it as it was.It occurred to two catheters.Associated to 9680794-2023-00700.Additional information: the kink in the catheter did not affect the treatment.The catheter was kinked 23cm from the tip.It was inserted in the right jugular vein.The catheter could be flushed without issue.No injury to the patient was reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: 17817775
• MDR Text Key: 324260787
• Report Number: 9680794-2023-00699
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: 10801902127256
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141051
• 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: 08/31/2023

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 Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F22H0666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED