MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15272-VF

Device Problem Leak/Splash (1354)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: the catheter was removed due to malfunction.Once removed the catheter seemed to have leaking around the lumens where it meets the body of the cath.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

Event Description

It was reported that: the catheter was removed due to malfunction.Once removed the catheter seemed to have leaking around the lumens where it meets the body of the cath.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 18318828
• MDR Text Key: 330386121
• Report Number: 9680794-2023-01003
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801902090201
• UDI-Public: 00801902090201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-15272-VF
• Device Lot Number: 13F22F0608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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