MAUDE Adverse Event Report: REDAX SPA SPIRAL DRAIN CH 10 WITH NEEDLE; ROUND FLUTED DRAIN CH 10

Model Number 24602

Device Problems Crack (1135); Obstruction of Flow (2423); Physical Resistance/Sticking (4012)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

The first analysis has been performed on the production documentation: dhr of the lot involved, was done of (b)(4) units that have been sold to the market.No deviations have been recorded on the production and control (visual, dimensional and functional) documents.Quality control have performed the tensile strength test, before product release, according to standards en 1617 and en 1618.Here below the values of break recorded: section a (fluted section): 57.6 n, 53.2 n, 52.9 n, 59.2 n, 58.1 n, 51 n, 56 n, 53.9 n, 51.5 n, 57.1 n, 60.5 n, 60.9 n.Section b ( gluing section): 47.6 n, 43 n, 47.4 n, 49.5 n, 45.5 n, 49.2 n, 49.4 n, 40.6 n, 51.8 n, 53.8 n, 50.8 n, 59.6 n.Section c (connection with needle): 38.3 n, 38.9 n, 38.7 n, 37.6 n, 37.2 n, 38.6 n, 39 n, 39.5 n, 40.4 n, 33 n, 46.7 n, 56.1 n.Section d (round section): 46.3 n, 52.1 n, 51.8 n, 52.9 n, 51.8 n, 51.4 n, 52 n, 52.5 n, 53 n, 48 n, 52.4 n, 57.6 n.The adopted acceptable limit values are more severe than those required by the standard (10 n is the value required by international standard for drainages <12 ch; 30 n is the limit required by redax internal procedure for drainage tubes 10 ch).The values recorded are much higher than the limit value.Complaint data base has been reviewed, as well as trend analysis to evaluate similar cases: trend on specific issue on the product code 24602: 2 complaints recorded, one during year 2011 and one during year 2010.Trend on all issue on specific lot f1708006: no complaints recorded.Trend on product family "spiral drain" with similar issue: no recent complaint.3 complaints recorded during 2011, 1 during 2010.Redax required the sample for further investigation.

Event Description

During manual drain removal, positioned the day (b)(6) 2018 on the patient in the lumbar zone, the drain was blocked and needed a higher strength in order to remove it.After some seconds of traction, the assistant heard the crack of the drain.

Event Description

During manual drain removal, positioned (b)(6) 2018 on the patient in the lumbar zone, the drain was blocked and needed a higher strength in order to remove it.After some seconds of traction, the assistant heard the crack of the drain.

Manufacturer Narrative

This report is a follow-up report after device evaluation.The manufacturer report number of the initial mdr is 3013058659-2018-00011.The sample has been received on 19th december 2018 and due to the christmas holidays, the analysis of it has been conducted later.The sample appears to be broken on the round tube, near the gluing between round and fluted sections.As reported in the initial report, the tensile strength values at break have been verified but the data don't show any deviation: the values recorded are much higher than the limit value required by the international standard.Moreover, last complaints recorded on similar cases both for product code (specific size ch 10) and family (spiral drain from ch 7 to ch 24) have been registered during year 2011 when different materials, with different characteristics were used.Current silicones are characterized by a good mechanical properties and high quality, consequently we can't do comparisons with these old complaints.We suppose that the rupture happened due to an excessive traction carried out on the tube during the removal or that the removal was difficult due to embedded tissues, or due to a weakened material not detected during production.Based on the above findings, it could not be excluded two cases: 1.Redax internal in process destructive tensile stress testing is based on a sample procedure.Even if this is based on worldwide accepted statistical concepts, there could be the case that a minimum % of finished products falls at the very queue or slightly outside the normal distribution of accepted values.2.Even if a double than prescribed value is used as the internal release value for in process controls, the above statistics and the reference norms could not avoid a minimum percentage of cases that, when during the removing of the drain from the patient, a tensile value above the one that could cause a rupture is exerted, should the case of a particularly stuck drain in the patient or any reason.It is concluded that the incident has been an isolated case, since we have no other complaint from the same batch and the functional tests don't show any defectiveness of the raw material or in the production process.There are any corrective/preventive actions to implement.

• Brand Name: SPIRAL DRAIN CH 10 WITH NEEDLE
• Type of Device: ROUND FLUTED DRAIN CH 10
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 8063856
• MDR Text Key: 129170565
• Report Number: 3013058659-2018-00011
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: 24602
• Device Catalogue Number: 24602
• Device Lot Number: F1708006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR