MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-21242-XN1A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "proximal extension line folder over and occluded line".After the catheter was placed, the physician flushed it and it was occluded.A new catheter was placed.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported "proximal extension line folder over and occluded line".After the catheter was placed, the physician flushed it and it was occluded.A new catheter was placed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one mac sheath, a dilator, and the product lidstock for analysis.Signs of use were observed on the returned components.Visual inspection of the catheter revealed a kink on the proximal extension line midway down the extrusion.The appearance of the damage is consistent with repeated or prolonged clamping of the extension line during use, and/or mispositioning of the extension line while the extrusion is clamped.The kink in the extension line was located 33mm from the distal end of the luer hub.The length of the sheath measured 115mm which is within the specifications of 115-119mm per product drawing.The distal and proximal extension lines were flushed using a lab inventory 10ml syringe to ensure patency.No leaks or blockages were observed in any region of the catheter.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "indwelling devices should be routinely inspected for desired flow rate, security of dressing, correct position, and for secure luer-lock connection." the customer report of a kinked extension line was confirmed through complaint investigation of the returned sample.A kink was observed on the proximal extension line.The appearance of the damage is consistent with repeated or prolonged clamping of the extension line during use.The device met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 17897761
• Report Number: 9680794-2023-00735
• Device Sequence Number: 6979990
• Product Code: FOZ
• UDI-Device Identifier: 10801902179293
• UDI-Public: 10801902179293
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• 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): 09/12/2023

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: 03/31/2025
• Device Catalogue Number: CDC-21242-XN1A
• Device Lot Number: 33F23F0786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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