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

Model Number	IPN033030
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the catheter was inserted on (b)(6) 2023 and on (b)(6) 2023 the patient was admitted for dialysis and the nurses state the red hub is cracked and leaking.No patient harm was reported.A hub repair kit was used to replace the exisiting hub.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The image shows a small crack in the arterial hub.The customer also returned one connector assembly from a hemodialysis kit for evaluation.Signs of use in the form of biological material were observed.Visual analysis revealed that the arterial luer hub contained a crack on the threads.In addition, a small fragment from the threads was partially separated from the luer hub.Microscopic examination confirmed the damage.The appearance of this damage is consistent with over-tightening on the hubs.A lab inventory syringe filled with water was attached to the extension lines and flushed.When flushing the arterial line, water was observed leaking out of the crack on the threads.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "repeated over tightening of bloodlines , syringes and caps will reduce connector life and could lead to potential connector failure".The report of a cracked luer hub was confirmed through complaint investigation.Visual analysis revealed that the arterial luer hub contained a crack on the threads.The appearance of the damage is consistent with overtightening or repeated tightening of the hub.Functional testing revealed that water leaked from the crack when flushing.A device history record review was performed, and no relevant findings were identified.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 for reports of this nature.Date of event corrected to 02-jun-2023.
Event or Problem Description
It was reported the catheter was inserted on (b)(6) 2023 and on (b)(6) 2023 the patient was admitted for dialysis and the nurses state the red hub is cracked and leaking.No patient harm was reported.A hub repair kit was used to replace the existing hub.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• 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: 17321389
• Report Number: 9680794-2023-00514
• Device Sequence Number: 17865874
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111117
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 09/30/2025
• Device Model Number: IPN033030
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 13F22J0748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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: HEMODIALYSIS; HEMODIALYSIS
• Patient Sex: Male