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

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: according to the doctor there was a blood leakage at the junction hub after the patient was moved to the ward, after insertion.Additional information: the catheter was replaced successfully.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for evaluation.The complaint of a catheter leak was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.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, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy." the customer report of a catheter leak could not be confirmed by visual inspection of the customer supplied photos.The photos show the lidstock information and the device but no evidence of a leak was observed.In addition, full 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: according to the doctor there was a blood leakage at the junction hub after the patient was moved to the ward, after insertion.Additional information: the catheter was replaced successfully.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened hemodialysis set, including one connector assembly, severed catheter body, compression sleeve, and compression cap, for analysis.Definite signs of use were observed on the components.Initial visual analysis revealed no obvious defects or anomalies.After identifying a leak during functional testing, a hole was observed on the catheter body.The edges of the separation appeared smooth and uniform, consistent with the appearance of interaction with a sharp instrument (needle, scalpel, etc.).The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly.Attach syringes to extension line hubs and open clamps.Blood should aspirate without difficulty from both extension lines.".The connector assembly was connected to the returned cath body using the compression sleeve and cap, and the assembly was leak tested.The extension lines were tested for liquid leakage per amrq-000075 rev.17 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.A leak was identified on the catheter body when testing both arterial and venous extension lines.It was identified that the hole was over both lumens.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "do not use sharp instruments near extension lines or catheter.".The customer report of a catheter body leak was confirmed through investigation of the returned sample.The hemodialysis catheter was functionally tested via a leak tester, which revealed a hole in the catheter body.The appearance of the hole was consistent with interaction with a sharp instrument, such as a needle or scalpel.A device history record review was performed and no relevant findings were identified to suggest a manufacturing issue.Therefore, based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: according to the doctor there was a blood leakage at the junction hub after the patient was moved to the ward, after insertion.Additional information: the catheter was replaced successfully.There was no reported patient harm or consequence.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: 17860296
• Report Number: 9680794-2023-00734
• Device Sequence Number: 20310630
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F23B0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 05/23/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/30/2023; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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; NOT REPORTED
• Patient Sex: Unknown