MAUDE Adverse Event Report: REDAX S.P.A. SPIRAL DRAIN FR 15; ROUND FLUTED DRAIN FR 15, CODE: GBX

Model Number	24603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Redax received the answers to the questions addressed to the user, relating to the time the devices remained on the patient (few days) and the photo showing the breakage.We verified the pictures.It is not possible to have particular indications about the breaking of the drain.As part of our investigation, we have verified the production lot record and all quality control documentation.No anomalies were detected.Based on the analysis of the production batch record (dhr), as well as the quality control and testing records, the product has been released after a full analysis and it is in compliance with the specifications.No deviation are observed at any stage.No product noncompliance was found.Furthermore, it is noted that the tensile tests conducted internally and associated with the production batch gave evidence of compliance with the internal procedure and the standard en iso 20697.In 2023 and 2024 we sold respectively (b)(4) pieces.No complaints were received from other countries for similar issues.We can reasonably say that this is an isolated case.
Event or Problem Description
During the drain removal, the tube has broken.The drain was kept in place for 3 days.The drain was in place with a holding suture.The break is below where the holding suture was placed.The patient required further surgery to remove the retained portion of the drain.

• Brand Name: SPIRAL DRAIN FR 15
• Common Device Name: ROUND FLUTED DRAIN FR 15, CODE: GBX
• Manufacturer (Section D): REDAX S.P.A.; via galileo galilei, 18; poggio rusco (mantova), italy 46025 ; IT 46025
• Manufacturer (Section G): REDAX S.P.A.; via galileo galilei, 18; poggio rusco, mn 46025 ; IT 46025
• Manufacturer Contact: gianluca boni ; via galileo galilei, 18; poggio rusco, mn 46025 ; IT 46025
• MDR Report Key: 21924364
• Report Number: 3013058659-2025-00001
• Device Sequence Number: 21010784
• Product Code: GBX
• UDI-Device Identifier: 08034139294940
• UDI-Public: 08034139294940
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 24603
• Device Catalogue Number: 24603
• Device Lot Number: F2406024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White