MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15312-VFE
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the catheter "fell out the same day the stitches were removed because the cuff didn't grow into the tissue, inflammation is not present".The issue occurred more than 30 days after insertion.No patient harm or injury was reported and no signs of local or systemic infection were observed.No medical intervention was required.A new catheter was inserted.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened chronic hemodialysis catheter set for evaluation.Based on the customer report, it is being assumed that the returned kit is a representative sample.The kit was opened to further inspect the components.Visual inspection of the catheter body, suture wings, and connector assembly revealed no obvious defects or anomalies.The catheter body length measured which is within the specifications of 49.4-51.4cm per product drawing.R & d engineers were contacted regarding this complaint investigation.They indicated there is no documented mechanism through which the returned catheter would grow into the tissues during use.Therefore, it is not an intended design of the product.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user , "do not use sharp instruments near extension lines or catheter.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the complaint of a migrated catheter could not be confirmed through complaint investigation of the returned sample.One representative kit was returned.No defects or anomalies were observed on the returned sample.R & d engineers were contacted and indicated that the catheter growing into the tissues is not an intended design of the product.Based on these circumstances, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported the catheter "fell out the same day the stitches were removed because the cuff didn't grow into the tissue, inflammation is not present".The issue occurred more than 30 days after insertion.No patient harm or injury was reported and no signs of local or systemic infection were observed.No medical intervention was required.A new catheter was inserted.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR
• Common Device Name: 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: 17948967
• Report Number: 9680794-2023-00747
• Device Sequence Number: 6818953
• Product Code: MSD
• UDI-Device Identifier: 10801902112870
• UDI-Public: 10801902112870
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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 Expiration Date: 11/30/2024
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: 13F21L0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Female