MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB; CATHETER, HEMODIALYSIS, NON-I

Catalog Number	CDC-25122-XU1A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Associated mdr#: 9680794-2023-00797.
Event or Problem Description
It was reported the physician attempted to place the catheter and on removing the wire he noted that it had frayed.He removed the catheter and wire.He then tried to insert a second catheter and the same thing happened.The catheter was not placed.Customer indicated a surgical consult was ordered and reported "i believe a vas cath was inserted the following day".Additional information received 23-oct-2023 from customer reports the issue was user error at the bedside.
Additional Manufacturer Narrative
Qn#(b)(4).Associated mdr#s: 9680794-2023-00797.The customer report of an unravelled guide wire was confirmed by visual inspection of the customer supplied photos.The photos show a used guidewire that is kinked in several locations and appears unraveled, however, no conclusions about the cause of the damage can be made from the photos alone.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the physician attempted to place the catheter and on removing the wire he noted that it had frayed.He removed the catheter and wire.He then tried to insert a second catheter and the same thing happened.The catheter was not placed.Customer indicated a surgical consult was ordered and reported "i believe a vas cath was inserted the following day".Additional information received 23-oct-2023 from customer reports the issue was user error at the bedside.

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 12 FR X 20 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18005068
• Report Number: 9680794-2023-00798
• Device Sequence Number: 6538956
• Product Code: MPB
• UDI-Device Identifier: 30801902123573
• UDI-Public: 30801902123573
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/02/2023

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: 05/31/2024
• Device Catalogue Number: CDC-25122-XU1A
• Device Lot Number: 13F22K0844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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