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

Model Number	IPN920475
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports "there was a blood leak at the level of the juncture hub.It made us think there could be a separation of the catheter from the jucture hub.".It was reported there was no consequence for the patient.The catheter was removed and a new one was inserted.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reports "there was a blood leak at the level of the juncture hub.It made us think there could be a separation of the catheter from the jucture hub.".It was reported there was no consequence for the patient.The catheter was removed and a new one was inserted.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one hemodialysis catheter for evaluation.Signs of use were observed on the catheter body.Visual inspection of the catheter revealed no obvious defects or anomalies.After functional inspection was performed (see below), further visual analysis of the sample was performed.The connector was disassembled, and it was noted that the green compression sleeve was missing from the assembly.Per the ifu, "the separate hub connection assembly is then fastened to the proximal end of the catheter using a compression sleeve and threaded compression cap (refer to figure 1)." this indicates the user did not assemble the catheter correctly per the ifu.The catheter body length measured 313mm to the juncture hub, which is within the specifications of 312-328mm per product drawing.The catheter body outer diameter measured 0.20775", which is within the specifications of 0.2075"-0.2085" per product drawing.The catheter was flushed using a lab inventory 5cc syringe to test for a leak.No leaks were observed anywhere on the catheter body.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.No leaks were found anywhere on the catheter body or extension lines.After the green compression sleeve was found to be missing (see visual), a lab inventory compression sleeve was obtained and the catheter was re-assembled using the compression sleeve.The leak test was performed again, and no leaking was observed.Therefore, the lack of compression sleeve in the original assembly was determined to be the cause of the leak.A device history record review was performed with no findings to suggest a manufacturing related cause.The instructions for use (ifu) provided with this kit warns the user, "the separate hub connection assembly is then fastened to the proximal end of the catheter using a compression sleeve and threaded compression cap (refer to figure 1).Warning: green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation." the customer report of leaking juncture hub was confirmed through complaint investigation.Visual and functional analysis revealed that the catheter leaked from the distal end of the connector fitting.Further analysis revealed that the green compression sleeve was not included in the assembly of the device, which is not the intended use.This likely contributed to the leaking encountered by the customer.Based on the customer report and the sample received, intentional use error likely caused or contributed to this event.The customer was contacted to inform them that the improper assembly of this device contributed to the observed failure mode.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: 15280359
• Report Number: 9680794-2022-00497
• Device Sequence Number: 7308002
• Product Code: MSD
• UDI-Device Identifier: 10801902195132
• UDI-Public: 10801902195132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 12/31/2024
• Device Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F22A0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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: Unknown