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

Model Number	IPN924881
Medical Device Problem Codes	Obstruction of Flow (2423); Connection Problem (2900)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported " on (b)(6) 2025, a patient with a pneumothorax had a drainage port with an exsufflation (heimlich) valve inserted.On (b)(6) 2025, the patient's valve became detached during his morning shower, and he reattached it himself.A nurse determined that the valve had been incorrectly attached.It was oriented incorrectly, thereby blocking liquid drainage.The patient had decreased saturation but was otherwise unharmed.This is the third similar incident involving the same device in the past 12 months." the patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.Associated mdr numbers include: 9680794-2025-00368 and 9680794-2025-00369.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported " on (b)(6) 2025, a patient with a pneumothorax had a drainage port with an exsufflation (heimlich) valve inserted.On (b)(6) 2025, the patient's valve became detached during his morning shower, and he reattached it himself.A nurse determined that the valve had been incorrectly attached.It was oriented incorrectly, thereby blocking liquid drainage.The patient had decreased saturation but was otherwise unharmed.This is the third similar incident involving the same device in the past 12 months." associated mdr numbers include: 9680794-2025-00368, 9680794-2025-00369, and 9680794-2025-00370.
Additional Manufacturer Narrative
(b)(4).Additional information from the customer received 19-may-2025 indicates "saturation after the disconnection was 88%, after the intervention the saturation increased back to 95%".The actual device involved in the event was not returned; however, the customer returned two unopened pneumothorax sets for analysis.No signs of use were observed.Visual analysis revealed no damage to the product packaging.One set was opened to analyze the contents within.No damage was observed to any of the components.The directional arrows printed on the heimlich valve were present and clear.Additionally, the valve tag, which contains directions regarding the valve directionality, was properly attached.The opened kit was then tested per the instructions for use (ifu) provided with this set.The ifu instructs the user, "check the direction of the arrow marked on the valve: the arrow must always be oriented in the direction of the drainage flow.Firmly attach one end of latex extension tube to proximal barbed fitting on heimlich valve.Attach other end of latex tube to tubing adapter." once assembled, the connections between the heimlich valve and the latex tubing as well as between the latex tubing and the tubing adapter were observed to be secure.A device history record review was performed, and no relevant findings were identified.The ifu instructs the user, "securely tape latex extension tube connections to minimize the risk of accidental disconnection." additional it 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 samples.The customer returned two unopened pneuomothorax sets for analysis.One set was opened for testing.Visual analysis revealed no defects or abnormalities to the heimlich valve, and the assembly 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.

• 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: 21950566
• Report Number: 9680794-2025-00370
• Device Sequence Number: 8358940
• Product Code: JOL
• UDI-Device Identifier: 00801902097897
• UDI-Public: (01)00801902097897(11)230810(17)260731(10)14F23H0061(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SV
• PMA/510(K) Number: K883905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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 Model Number: IPN924881
• Device Catalogue Number: AI-01500-E
• Device Lot Number: 14F24E0133
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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