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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the extension line was found leaking during use on the patient and was changed to a new one.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one photo and a video for analysis.Visual inspection of the video was not able to confirm a leak.Blood was observed on the threads of the connector assembly, but the compression cap was not fully tightened (threads were visible) at the beginning of the video.It is unknown if the user had the compression cap fully tightened during use when they observed the leaking.During the video, the user loosened and retightened the compression cap fully.No blood was observed leaking during this process.Visual inspection of the photo revealed the compression cap appeared crushed at the proximal end.The customer also returned one connection assembly for analysis.The compression cap was damaged; both the distal and proximal ends appeared crushed.The appearance of the damage is consistent with the use of needle holders to tighten or loosen the cap.No other damage was noted to the assembly.The inner diameter of the compression cap was not able to be accurately measured due to the damage.The connector assembly was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s)." when the assembly was flushed no leaks or bloc ks were detected.The compression cap was disassembled from the connector assembly and reassembled with a lab inventory catheter body.The assembly was leak tested per (b)(4) which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per (b)(4) annex c." both luer hubs of the catheter were connected to the leak tester separately and pressurized to 300kpa while the distal end of the catheter was occluded.30 seconds passed with no leaks detected for either line.A device history record review was performed, and five findings were identified.A non-conformance (nc) was initiated for lot# 13c20d1444 in regards to "tunneler/catheter disconnection".This nc is not relevant to this complaint.Additionally, four nc's were identified for the issue of compression cap damaged/defective.The damage observed in these ncs consisted of crack along the molding seam.That is not consistent with the damage observed to the compression cap in this complaint.The ifu provided with this kit instructs the user, "thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly." the customer complaint of a catheter leak was not able to be confirmed by functional inspection or by the customer supplied photo and video.The customer video revealed blood on the connector assembly threads, but it could not be determined if this was due to the compression cap being partially disassembled, as there were treads visible on the connector assembly.The ifu states, "there should be no threads visible on hub connection assembly." when the returned connector assembly and compression cap were functionally tested with a lab inventory catheter body, no leaks were detected.Based on the customer description and the sample returned, the root cause could not be determined without the catheter body returned for analysis.No defects were observed on the returned connector assembly.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported the extension line was found leaking during use on the patient and was changed to a new one.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 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: 16063746
• MDR Text Key: 308368283
• Report Number: 9680794-2022-00790
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/04/2022

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: 01/31/2024
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F21L0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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