MAUDE Adverse Event Report: REDAX SPA SMART DRAIN CH 15; ROUND FLUTED DRAIN CH 15

Model Number 24715

Device Problem Complete Blockage (1094)

Patient Problem Hematoma (1884)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4), has visited and met the health professionals involved in this case and the following is what they have reported: the main complaint is that the drain is too soft; they say that due to this when the drain bends, it kinks and become occluded which has led to a patient having an haematoma and consequently further surgical treatment.Similar complaint is reported with incident report (b)(4) (redax ref.(b)(4)).The first analysis has been conducted on the production documents of the involved lot: no deviations have been observed on the production and on the labeling and qc records.The lot is made of (b)(4) units; no stock is available, all the units have been distributed on the market.Complaint data base has been reviewed, as well as trend analysis to evaluate similar cases in the last 2 years: trend on specific issue on the product code 24703.No complaints recorded.Trend on all issues on specific lot no.F1801101.No complaints recorded.Trend on product family with similar issue.Complaint from (b)(4).Since the sample was not available for analysis, we have taken from our stock some units coming from other lots in order to performs technical verification.Redax drains have been validated and are in compliance with european standard en 13868 "catheters - test methods for kinking of single lumen catheters and medical tubing" and with en 1618 appendix e relative to the drain flow.However we have repeated the tests in order to evaluate kink resistance and the length of the tubing loop in the kinking and the flow value of smart drain ch 15.The results of the tests indicate that is difficult to perform kinking test according to the standard: it is more difficult when the drain size is more little.However the kink length is < 2 cm for all the sample tested.The length of kinking doesn't change between redax and competitors' drains being equal size; while the flow is upper in redax' drains instead competitors ones.This comparison with competitors has been done only with drain ch 10.No actions will be performed.The tube is in compliance with the international standards and no further complaints have been registered on this product family relative to this specific issue.We have registered the same issue only in the same hospital.

Event Description

Suggestion by consultant that these drains have become blocked resulting in haematoma formation and breakdown of diep flap procedure.This pt has required return to theatre for a 2nd and 3rd stage reconstruction with the surgeon stating it is directly related to the drain issues.

• Brand Name: SMART DRAIN CH 15
• Type of Device: ROUND FLUTED DRAIN CH 15
• 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: 7959367
• MDR Text Key: 125933014
• Report Number: 3013058659-2018-00008
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/22/2023
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: F1801101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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): Hospitalization