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 Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Mdr 1049092-2020-00182 / device 1 of 1.(b)(6).Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that a "(b)(6)-year-old covid intensive treatment unit (itu) patient with bowel management system in situ developed catastrophic rectal bleeding.Angiography revealed a false aneurysm arising from a branch of the superior rectal artery- successfully embolized." patient required transfusion of four (4) units of blood and six (6) units of fresh frozen plasma and was transferred to another itu within the hospital for interventional radiology.Upon follow up with user facility it was reported that a rectal exam was done prior to insertion on (b)(6) 2020, by an experienced registrar.Forty-five (45) ml was inserted into the retention balloon of the product.¿ the black line on the tube was confirmed as visible directly outside the anus.There was no malfunction noted with the product during insertion or during use.No photograph depicting the reported complaint issue was received from the complainant.

Manufacturer Narrative

No sample or picture received.Review of the qc record and production records yielded no abnormal issues found.Retention samples yielded the appearance to be normal and the balloon/inflation port and valve function normal.Possible causes for this complaint include the following: 1.When inserting the fms in a long-term bedridden, longer sitting and other diseases may result in the raise of pressure to the abdominal cavity and are possible factors to raise the pressures in the anus and rectum.2.Friction between the catheter and the anus might cause anal injury.If the balloon is not placed in the rectum completely this might cause anal injuries.3.The contraindications list should be adhered to.Since the complaint did not cause or contribute to a death or serious deterioration in the state of health of the patient, no corrective actions need to be taken.The incident will be identified and included in the risk management report/post-market surveillance report.Supplier investigation: root cause and investigation: 1.Design and intended use: flexi-seal fecal management system is designed to provide a channel for users to manage patients¿.Fecal incontinence, and to collect the liquid and semi-liquid stool in order to protect the patient¿s skin.And keep the bedding clean, and to provide access to administer medications as ordered by a physician, and to collect a stool sample.2.Manufacturing process: 2.1 production process and qc record: 2.1.1 accessories ¿ manufacturing process of the indicator bubble: die-casting, indicator balloon test, printing, cutting, gluing and assembling.2.1.2 the manufacturing processes of fms kit including printing, air hole punching, pocket processing, balloon adhesion, irrigation/ inflation port assembling, and inflation indicator assembling etc.The balloon test of full-inspection will be performed after processing.Check the balloon and inflating chamber for malfunction.If the malfunction occurred when inflating or deflating the balloon, it will be detected and recorded.Defects may not be delivered.2.1.3 quality records: review the qc record and production records of 418000 (sap code: 1705108), lot no.: 18fm0428 there are no abnormal issue founded.2.2 retention samples review: 4 pcs retention samples of 418000 (sap code: 1705108), lot no.: 18fm0428 manufacture order no.: (b)(4).The appearance of balloon/ inflation port, catheter body and valve function are normal.3.Complaint simulation testing:n/a.4.Other possible causes for this complaint: 4.1 when inserting flexi-seal fms kit management system, long-term bedridden, longer sitting and the diseases that may result to raise the pressure of abdominal cavity are the possible factors to raise the pressures of anus and rectum.These pressures, together with the pressure coming from the inflated balloon or friction between the catheter and the anus of flexi-seal fms kit management system may result to the damages of anus and rectum tissues.4.2 when inserting flexi-seal fms kit management system, friction between the catheter and the anus might cause the anal injury.The balloon did not be placed in the rectum completely, also might cause anal continuing to withstand balloon pressures and injuring the anus.4.3 product contraindications instructions are described: the flexi-seal fms kit management system should not be used on individuals who - have suspected or confirmed rectal mucosal impairment, e.G.Severe in proctitis, ischemic proctitis, mucosal ulcerations.- have rectal surgery within the last year - have any rectal or anal injury - have hemorrhoids of significant size and/or symptoms - have a rectal or anal stricture or stenosis - have a suspected or confirmed rectal/anal tumor - have any in-dwelling rectal or anal device (e.G.Thermometer) or delivery - mechanism (e.G.Suppositories or enemas) in place are sensitive to or who have had an allergic reaction to any components within the kit.Conclusion: 1.When inserting flexi-seal fms kit management system, long-term bedridden, longer sitting and the diseases that may result to raise the pressure of abdominal cavity are the possible factors to raise the pressures of anus and rectum.These pressures, together with the pressure coming from the inflated balloon or friction between the catheter and the anus of flexi-seal fms kit management system may result to the damages of anus and rectum tissues.And during inserting process, it may result to the damage of anus, and if the balloon of flexi-seal fms kit management system does not insert into rectum entirely, it may make anus sustain the pressure coming from the balloon continually, of which may result to the damage of anus too.2.Product use possible adverse reactions: instructions are described: if the patient¿s bowel control, consistency and frequency of stool begin to return to normal, discontinue use of the device.As with the use of any rectal device, the following adverse events could occur: - leakage of stool around the device - rectal/anal bleeding due to pressure necrosis or ulceration of rectal or anal mucosa - perianal skin breakdown - temporary loss of anal sphincter muscle tone -infection -bowel obstruction -perforated bowel to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 1049092.

Event Description

To date no additional patient or event details have been received.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 10864296
• MDR Text Key: 217092920
• Report Number: 1049092-2020-00182
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Device Lot Number: 18FM0428
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1