MAUDE Adverse Event Report: REDAX SPA SMART DRAIN CH 19; ROUND FLUTED DRAIN

Model Number	24719
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Production documents have been reviewed as well as qc in process controls.No deviations found on the batch involved.The values recorded for tensile strength test at break of the drain are in compliance with iso 20697:2018, actually much higher than required by the standard (> 150n).The mechanical properties of the silicone material, which the drain is made of, guarantees good resistance to break if the tube is not damaged.We assume that an accidental damage of the tube caused the breakage before the tube was removed from the patient.Further evaluations will be done after receiving the sample.
Event or Problem Description
On (b)(6): redo avr, the drain tube was used for right chest drainage.On (b)(6): no fluid or blood drainage are confirmed.On (b)(6): drain tube removal.There was no resistance at all while pulling to remove, then performed x-ray and found the broken tube was remaining in the bosy.On (b)(6): removed by laparoscopic surgery.

• Brand Name: SMART DRAIN CH 19
• Common Device Name: ROUND FLUTED DRAIN
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 12364876
• Report Number: 3013058659-2021-00001
• Device Sequence Number: 3812110
• Product Code: GBX
• UDI-Device Identifier: 08034139295206
• UDI-Public: 08034139295206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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 Expiration Date: 04/16/2025
• Device Model Number: 24719
• Device Catalogue Number: 24719
• Device Lot Number: F2004131
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization