MAUDE Adverse Event Report: REDAX SPA FLAT DRAIN TYPE JACKSON-PRATT

Model Number 24130

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

After having received the complaint , we have performed analysis of the production documentation: dhr of the lot involved, was done of (b)(4) units: (b)(4) in stock at our internal warehouse, the remaining has been put on the market.No deviations have been recorded on the production and control (visual, dimensional and functional) documents.Due to the type of defect claimed, it was considered not necessary to verify further units of the same lot in stock.Complaint data base has been reviewed, as well as trend analysis to evaluate similar cases: trend on specific issue on the product code 24130: no complaints.Trend on all issue on specific lot f18107141: no complaints recorded.Trend on product family "flat silicone drain type jackson-pratt" with similar issue: (b)(4) case recorded during 2014, but not significant because the product was produced with different production process.Since the defective unit is not available, we have contacted the doctor to ask more details and the information collected are the following: the patient was not affected by any particular medical condition; the drain was not blocked by sutures or other; the type of operation performed: intestinal recanalization with colorectal anastomosis.The doctor claims a difficulty to remove the drain and the necessity to use a bigger force.After having collected these information and considering to not have received other similar complaints, we have supposed that the problem could be associated to the specific type of operation performed.Looking at the literature, this procedure requires a lot of sutures and, even if the doctor declares that the drain was not blocked, it was possible that the tube was fixed.Otherwise, since the device is produced in silicone, material with high compatibility with human body, a tissue invagination could be happened.The drain is produced with high performance material, soft and smooth that conforms to anatomical structures to provide patient comfort.This drain is widely used for different type of surgery: redax sold worldwide (b)(4) units during year 2018 and (b)(4) during year 2017.The absence of further similar complaints demonstrates that the product is safe and no specific risk of retention in the body has been recorded.We will monitor any further complaint in order to evaluate if any action will be required in future.

Event Description

After two attempts to remove the drain in the abdominal cavity, the doctor decided to remove it in the operating theatre due to difficulty in the operation.

• Brand Name: FLAT DRAIN TYPE JACKSON-PRATT
• Type of Device: FLAT DRAIN TYPE JACKSON-PRATT
• 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: 8521634
• MDR Text Key: 144262931
• Report Number: 3013058659-2019-00002
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: 24130
• Device Catalogue Number: 24130
• Device Lot Number: F1807141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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