MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW NEXTSTEP RETROGRADE REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI

Catalog Number	NRH-15232
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the luer hub/fitting was crack during used on the patient." the user switched to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the luer hub/fitting was crack during used on the patient." the user switched to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one hemodialysis connector assembly for evaluation.Signs of use were observed on the returned device.Visual inspection of the connector revealed the arterial (red) luer hubs was cracked at the threads.This damage is consistent with repeated overtightening of the hub during use.A lab inventory syringe filled with water was attached to both extension lines and flushed.Water was observed leaking out of the crack on the arterial luer hub's 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 and signs of scratches on the threads.The appearance of the damage is consistent with overtightening or repeated tightening of the hubs.Functional testing revealed that water leaked from the cracks 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.

• Brand Name: ARROW NEXTSTEP RETROGRADE REPLACEMENT HUB SET
• Common Device Name: KIT, REPAIR, CATHETER, HEMODI
• 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: 19219837
• Report Number: 9680794-2024-00353
• Device Sequence Number: 8106004
• Product Code: NFK
• UDI-Device Identifier: 00801902096807
• UDI-Public: 00801902096807
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 10/31/2024
• Device Catalogue Number: NRH-15232
• Device Lot Number: 13F21L0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/05/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown