MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18GA X 12CM; CATHETER, PERCUTANEOUS

Model Number	IPN030324
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: during inspection of the stock for nationalization label it observed that the guide is not straight.Packaging is closed.No patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing two sac kit lidstocks.The guide wires were also pictured within their respective packaging.Visual analysis revealed that the guide wires were slightly kinked within the guide wire tubing; however, a probable cause of the kinking cannot be determined from the photos and without the sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "do not use if package has been previously opened or damaged".The report of a kinked guide wire before use was confirmed through analysis of the customer supplied photos.The images revealed that the guide wire was kinked within the packaging; however, the actual complaint sample was not returned for evaluation.A device history record review was performed, and no relevant findings were identified.The probable cause of the guide wire kinking could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: during inspection of the stock for nationalization label it observed that the guideis not straight.Packaging is closed.No patient involvement.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 12CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12954962
• Report Number: 3006425876-2021-01129
• Device Sequence Number: 14532344
• Product Code: DQY
• UDI-Device Identifier: 00801902102799
• UDI-Public: 00801902102799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: 07/16/2024
• Device Model Number: IPN030324
• Device Catalogue Number: SAC-01218
• Device Lot Number: 71F19G0784
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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