MAUDE Adverse Event Report: REDAX SPA SMART DRAIN COAXIAL CH 28; SILICONE FLUTED DRAIN CH 28

Model Number 24726

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The problem happened during a trial made to evaluate the device from a new user.The same problem was claimed on code# (b)(4) coaxial drain ch 24; lot#: f2003060 too.We asked for several questions in order to investigate the cause, but after 3 calls we didn't receive any answer.Consequently no investigation has been done for missing information.We don't have any similar issue on our complaint database on the lot involved and in all other lots produced, so we can presume that the device is not defective.However, in the document review, we have noted the en ifu claims that the drainage "prevent tube occlusion", due to a translation error and misinterpretation of the (b)(6) version.We will review the ifu with correct words.

Event Description

The drains have been used for a trial, but the doctor claimed they did not provide the drainage the way he expected them to.Both cases had to go back to the or for retained fluid and clot.

• Brand Name: SMART DRAIN COAXIAL CH 28
• Type of Device: SILICONE FLUTED DRAIN CH 28
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer (Section G): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer Contact: daniela malavasi ; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 10926625
• MDR Text Key: 219382011
• Report Number: 3013058659-2020-00001
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24726
• Device Catalogue Number: 24726
• Device Lot Number: F1911058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2019
• 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