MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB; CATHETER, HEMODIALYSIS, NON-I

Catalog Number	CDC-22122-XU1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the pre-insertion setup, the inserting clinician opened the first kit and observed a kink in the distal tubing/lumen.The first catheter/kit was removed, and a second catheter/kit from the same item/lot was opened.The second catheter had the same kink as the first; however, due to the emergent nature of the procedure, the inserting clinician proceeded to insert it into the patient.The second catheter, was placed, did function well during use & did not cause any issue.There was a slight delay in therapy as additional time was required to grab the second kit from inventory.The patient condition was reported as "fine," with no patient injury, consequence, or medical intervention required.
Event or Problem Description
It was reported that during the pre-insertion setup, the inserting clinician opened the first kit and observed a kink in the distal tubing/lumen.The first catheter/kit was removed, and a second catheter/kit from the same item/lot was opened.The second catheter had the same kink as the first; however, due to the emergent nature of the procedure, the inserting clinician proceeded to insert it into the patient.The second catheter, was placed, did function well during use & did not cause any issue.There was a slight delay in therapy as additional time was required to grab the second kit from inventory.The patient condition was reported as "fine," with no patient injury, consequence, or medical intervention required.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB
• Common Device Name: CATHETER, HEMODIALYSIS, NON-I
• 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: 20986672
• Report Number: 9680794-2024-01260
• Device Sequence Number: 8581372
• Product Code: MPB
• UDI-Device Identifier: 30801902123504
• UDI-Public: (01)30801902123504(11)240711(17)250930(10)33F24D0302(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: CDC-22122-XU1A
• Device Lot Number: 33F24D0302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2024
• 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
• Patient Sex: Unknown