MAUDE Adverse Event Report: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 6F X 20CM; CATHETER, CONTINUOUS IRRIGATION

Model Number	756606020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
I need to report an incident we had with an argon drain 6 fr.Dr (b)(6) placed a pigtail drain in the right pleural space for pleural effusion in an icu patient.When he pulled the pigtail tight for secure placement, the stitch broke, and he could not secure the drain.Dr had to replace the drain with a new 6fr drain, which was unfortunate due to the increased risk of complications to the patient.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 6F X 20CM
• Common Device Name: CATHETER, CONTINUOUS IRRIGATION
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22572151
• Report Number: 0001625425-2025-01056
• Device Sequence Number: 13173398
• Product Code: GBQ
• UDI-Device Identifier: 00886333225064
• UDI-Public: (01)00886333225064(17)290124(10)11556405
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 756606020
• Device Lot Number: 11556405
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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
• Patient Sex: Unknown