MAUDE Adverse Event Report: ARGON MEDICAL DEVICES F8 SKATER DRAINAGE CATH . 25CM; CATHETER, CONTINUOUS IRRIGATION

Model Number	751108025E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
During a drainage management of the thoratic cavity, the pigtail had been placed in vivo for about 8¿9 days when the doctor found that it had broken into two pieces from the white hub, causing the patient to develop pneumothorax.The patient was then placed in a chest tube and transferred to the icu care.The faulty product returned from the hospital included only the pigtail and was found without an outer package.We have provided a photo for your reference to show the faulty condition.
Additional Manufacturer Narrative
A comprehensive review of the manufacturing and inspection records for this lot has been completed.No deviations or non-conformances were identified.One opened sample was returned by the customer for examination.A visual inspection was conducted on the returned product.It was observed that the catheter was broken near the hub.The damaged to the catheter seems to happen in the user¿s environment and it is hard to tell the exact reason.The complaint was confirmed.No corrective action was taken at this time since the issue seems not be related to any issue during manufacturing.Additional information provided in d.9., h.3., h.6.And h.11.

• Brand Name: F8 SKATER DRAINAGE CATH . 25CM
• Common Device Name: CATHETER, CONTINUOUS IRRIGATION
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 21610375
• Report Number: 0001625425-2025-00969
• Device Sequence Number: 12686449
• Product Code: GBQ
• UDI-Device Identifier: 00886333000043
• UDI-Public: (01)00886333000043(17)290610(10)11575839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 751108025E
• Device Lot Number: 11575839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian