MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM); WIRE, GUIDE, CATHETER

Model Number	IPN036993
Medical Device Problem Codes	Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "the ra-04020 catheter within kit, was placed in the operating room on (b)(6) 2022, with no complications.2 days later, respiratory therapy was asked to assess failed/failing arterial line, with report that it leaked during flushing.Also noted poor waveform, without pressure reading.Attempted to draw blood & noticed a small amount of blood leaking at puncture site.Removed dressing and noted that catheter was kinked at hub.Withdrew catheter slightly to examine further, and noted another kink approximately 1/2 cm distal to the first kink.Blood oozing from kink at hub.Attempted to flush using pigtail, and observed clear fluid spraying from side of catheter at kink.When flushing stopped, blood again oozed from catheter.Catheter was immediately removed and replaced without issue." no patient injury was reported.The patient's condition is reported as fine.
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 RA CATH KIT: 20 GA X 1-3/4" (4.45 CM)
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16382816
• Report Number: 9680794-2023-00072
• Device Sequence Number: 5898548
• Product Code: DQX
• UDI-Device Identifier: 10801902117813
• UDI-Public: 10801902117813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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
• Report Date (Section B): 01/18/2023

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: 03/31/2024
• Device Model Number: IPN036993
• Device Catalogue Number: ASK-04020-SPH
• Device Lot Number: 13F22K0099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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.
• Patient Sex: Unknown