MAUDE Adverse Event Report: CONVATEC INC FMS SIGNAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Ulceration (2116); Blood Loss (2597)

Event Date 03/23/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional patient/event details have been requested but, not provided to date.The lot number was not provided.Therefore, we are unable to determine the specific third party manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported that an "injury was identified by staff over weekend, i saw the patient on monday (b)(6).Looking back at the chart the flexi seal was on day twenty-seven (27) of insertion.I removed the tube, noted the injury and am now working with staff about the appropriate interventions when dealing with flexis.The biggest issue i identified with this patient was that the tube was placed in intensive care unit, patient transferred to step-down and then to medical/surgical" unit.The injury was initially identified on (b)(6) 2019 (day 23 of use) "erosion/pressure injury to anoderm that was noted with slight blood in fecal management system (fms)" and was not removed by staff until (b)(6) 2019 (day 25).Upon inspection of surgeon the injury was described as "ulceration at anoderm, full thickness, internal sphincter is visible at the ulcer bed.Ulceration extends past dentate line into distal rectum".Calmoseptine was applied after removal of the fms, but nothing was applied when the erosion was noted on (b)(6) 2019.Per the user facility the patient had been on a turn/reposition program.It is unknown if a rectal exam was performed prior to placement of fecal management system.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8532863
• MDR Text Key: 142534318
• Report Number: 1049092-2019-00188
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SKIN BARRIER OINTMENT
• Patient Age: 57