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

Model Number 756608035

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Sample is not available for return.Argon requested additional information to execute proper investigation for this reported event.

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 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
• Type of Device: 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
• MDR Text Key: 321683797
• Report Number: 0001625425-2023-01172
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00886333225132
• UDI-Public: 00886333225132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other