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	Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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." 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, 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%".This event regarding the patient desaturation was captured in mdr#9680794-2025-00370.The customer has stated "this is the third similar incident involving the same device in the past 12 months"; therefore, three mdrs were filed.The customer has only reported information regarding one patient.The other event details from the two previous events are unknown.Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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".Associated mdr numbers include: 9680794-2025-00368, 9680794-2025-00369, and 9680794-2025-00370.

• 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: 21950403
• Report Number: 9680794-2025-00368
• Device Sequence Number: 18422373
• 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,User Facility
• 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?: No
• 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?: Yes
• 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: 05/31/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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