MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 35CM

Model Number	755108035
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the sample will get returned for investigation or not.Argon requested sample back.A follow-up report will be submitted upon investigation completion and if new information is available.
Event or Problem Description
Same problem is occurring in several patients (12 at least): 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; although the hospital needs free units of device for replacements from different lots.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.After third notification, sample was not returned to argon.The complaint was closed.No corrective required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
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 bio-contamination during the handling of the rescued devices; although the hospital needs free units of device for replacements from different lots.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 35CM
• 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: 16870984
• Report Number: 0001625425-2023-01039
• Device Sequence Number: 5796524
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 755108035
• Device Catalogue Number: 755108035
• Device Lot Number: 11440257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown