MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM

Model Number	756608025
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for return.Argon is investigating this event and a follow-up report will be submitted after investigation completion.
Event or Problem Description
The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.Very unpleasant.Has anything changed in the make.
Event or Problem Description
The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.Very unpleasant.Has anything changed in the make?.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.The purple connector that was removed from the kit pinched off the suture sleeve tube when inserted into the female luer thereby keeping and liquid/fluid out of the chamber that the suture string passes through.Without the purple adapter being pushed into the female luer tube and pinching off the suture tube, fluid/liquid is flowing freely into the luer chamber that the string passes through and will always leak out of the hole formed by the string passing through the luer wall.Capa ca-00047 has been issued to determine the cause and appropriate corrective action(s) required, as well as determining the risks associated with this issue.Root cause was identified as design issue and necessary actions are being implemented to address this issue under capa ca-00047.
Additional Manufacturer Narrative
Please see updated investigation report: upon further review and lacking a sample for forensic analysis we cannot arrive at a conclusive cause for the air leakage reported by the customer.
Event or Problem Description
The come across a problem with the pleural drain insert, 6 and 8 f, namely when aspiration only air or a large amount of air comes out and any pneumothorax could not be confirmed during the check with ct.There has also been air at the coupling with a three-way valve and the collection bag.So everything that the customer have done before according to our routines.So suspected air intake from the thread opening, customer assume.It has been noted during the last 2 weeks.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM
• Common Device Name: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17797405
• Report Number: 0001417485-2023-00001
• Device Sequence Number: 7041604
• Product Code: GBO
• UDI-Device Identifier: 00886333217786
• UDI-Public: 00886333217786
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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: 756608025
• Device Lot Number: 11480296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/01/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/13/2023; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown