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

Model Number IPN033030

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event 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.

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 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
• 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: 17321389
• MDR Text Key: 319134027
• Report Number: 9680794-2023-00514
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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: HEMODIALYSIS; HEMODIALYSIS
• Patient Sex: Male