MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 8F X 35CM

Model Number	756608035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event 2: problem pulling pigtail drain.When pulling the pleural drain, the green/blue drainage tube itself comes out without problems, but a new thread (which is inside the green/blue tube) remains inside the skin and cannot be pulled out.Sticks rock hard.This provided that the knots were properly dissolved.The patient has only had his drain for two days actions taken tried to cut one end of the wire, but it still won't pull out.Enlists the help of dr.(b)(6) coming to the patient.Together we try to pull it out and then cut the other end of the wire to detach the drain hose itself.Holds the thread with tweezers.However, there is such pressure in the nylon thread that it is torn away from the tweezers and sucked into the skin again.The patient thus still has some nylon thread inside the body.The patient is informed and it is documented by the doctor in the medical record.
Additional Manufacturer Narrative
Sample is not available for return.Argon requested additional information to execute proper investigation for this reported event.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.According to the customer, no sample was available to return for evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, determining root cause or corrective action is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
Event 2: problem pulling pigtail drain.When pulling the pleural drain, the green/blue drainage tube itself comes out without problems, but a new thread (which is inside the green/blue tube) remains inside the skin and cannot be pulled out.Sticks rock hard.This provided that the knots were properly dissolved.The patient has only had his drain for two days.Actions taken tried to cut one end of the wire, but it still won't pull out.Enlists the help of dr.Wiltz coming to the patient.Together we try to pull it out and then cut the other end of the wire to detach the drain hose itself.Holds the thread with tweezers.However, there is such pressure in the nylon thread that it is torn away from the tweezers and sucked into the skin again.The patient thus still has some nylon thread inside the body.The patient is informed and it is documented by the doctor in the medical record.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 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: 17597200
• Report Number: 0001625425-2023-01172
• Device Sequence Number: 17775812
• Product Code: GBO
• UDI-Device Identifier: 00886333225132
• UDI-Public: 00886333225132
• 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
• Report Date (Section B): 10/03/2023

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: 756608035
• Device Lot Number: 11479403
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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