MAUDE Adverse Event Report: ARGON MEDICAL DEVICES F8 SKATER DRAIN CATH. STRING

Model Number	755108035E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
Physician reports that in the connector of the implanted catheter, through the hole where its anchor thread passes, the liquid that the catheter is draining also comes out; because that outlet hole is not well sealed and the internal valve of the catheter does not work either.The result is that the doctor must change the catheter and is a danger because of the great possibility of infections of the area where the catheter comes out.Obtaining samples from the failed catheters explanted is practically impossible due to the great possibility of dangerous biocontamination during the handling of the rescued devices.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Argon evaluated returned product from the customer.Visual inspection confirmed that returned product was unopened and no damages were noticed on the product.Functional inspection confirmed that there were no leakage from the device.Product complaint mode could not duplicated during the evaluation and the complaint was not confirmed.No corrective action is required at this time because a manufacturing defect could not be confirmed.
Event or Problem Description
Physician reports that in the connector of the implanted catheter, through the hole where its anchor thread passes, the liquid that the catheter is draining also comes out; because that outlet hole is not well sealed and the internal valve of the catheter does not work either.The result is that the doctor must change the catheter and is a danger because of the great possibility of infections of the area where the catheter comes out.Obtaining samples from the failed catheters explanted is practically impossible due to the great possibility of dangerous biocontamination during the handling of the rescued devices.

• Brand Name: F8 SKATER DRAIN CATH. STRING
• 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: 17050505
• Report Number: 0001625425-2023-01081
• Device Sequence Number: 7067305
• Product Code: GBQ
• UDI-Device Identifier: 00886333000166
• UDI-Public: 00886333000166
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 755108035E
• Device Catalogue Number: 755108035
• Device Lot Number: 11451034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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; Required Intervention
• Patient Sex: Unknown