MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PNEUMOTHORAX SET; CATHETER AND TIP SUCTION

Model Number	IPN924881
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	03/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the patient was fitted with a heimlich valve.On (b)(6) 2024, while the patient was hospitalized, her heimlich valve became detached.She then reattached it incorrectly on her own (without telling the hospital staff about it).During this incident, the patient showed signs of tension pneumothorax (dyspnea, decreased oxygen saturation).When the hospital staff noticed this, they called the duty doctor, who then refitted the hemlich valve correctly.The patient's condition subsequently improved." additional information received states "saturation after the disconnection was 88%, after the intervention the saturation increased back to 95%.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned one pneumothorax set for analysis.Signs of use were observed.Upon receipt, the heimlich valve was properly assembly to the connection tubing.Visual analysis revealed a kink in the tubing assembly.No defects or abnormalities were observed on the catheter, stopcock, or heimlich valve.The printed arrows on the heimlich valve were present and clear.The returned heimlich valve was functionally tested.A lab inventory stopcock was used to connect the extension tubing to a lab inventory syringe filled with water.The assembly was able to be successfully flushed.Then, a negative pressure was pulled on the assembly.When released, the syringe plunger returned to its original position, indicating that no air was allowed to pass back through the assembly.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, " warning: heimlich valve must be assembled properly to minimize the risk of tension pneumothorax.Refer to flow direction arrow on valve." the customer complaint of incorrect assembly of the heimlich valve was able to be confirmed through investigation of the returned sample.Visual analysis revealed no defects or abnormalities to the heimlich valve, and the valve passed relevant functional testing.A device history record review was performed, and no relevant findings were identified.Based on the customer report and sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "the patient was fitted with a heimlich valve.On (b)(6) 2024, while the patient was hospitalized, her heimlich valve became detached.She then reattached it incorrectly on her own (without telling the hospital staff about it).During this incident, the patient showed signs of tension pneumothorax (dyspnea, decreased oxygen saturation).When the hospital staff noticed this, they called the duty doctor, who then refitted the hemlich valve correctly.The patient's condition subsequently improved." additional information received states "saturation after the disconnection was 88%, after the intervention the saturation increased back to 95%.The patient's current condition is reported as "fine".

• Brand Name: ARROW PNEUMOTHORAX SET
• Common Device Name: CATHETER AND TIP SUCTION
• 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: 22096648
• Report Number: 9680794-2025-00450
• Device Sequence Number: 20838774
• Product Code: JOL
• UDI-Device Identifier: 00801902097897
• UDI-Public: (01)00801902097897(11)230906(17)260831(10)14F23J0015(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K883905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: IPN924881
• Device Catalogue Number: AI-01500-E
• Device Lot Number: 14F23J0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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: Female