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

Model Number 418000

Device Problem Device Handling Problem (3265)

Patient Problems Ulceration (2116); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Based on the available information, this event is deemed to be a serious injury.The product was used off label per section c.Insertion of device: inflate the balloon with up to 45ml of fluid by slowly depressing the syringe plunger.With the insertion finger removed, the signal¿ dome will indicate once the balloon has reached the optimal fill level for the anatomy.(figure 5) there may be cases where the signal¿ dome will not indicate if the space in the rectum is large.Under no circumstances should the balloon be inflated with more than 45ml of fluid.If the signal¿ dome indicates at less than 30ml of fluid, withdraw the fluid and reposition the balloon in the rectal vault.After repositioning, fill the balloon as described above.Do not fill with more than 45ml of fluid.This complaint has been evaluated.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.Since the lot number was not provided, we are unable to determine the specific 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 "the retention balloon was found to be overinflated to 70 milliliters (ml).The patient developed an ulceration with bleeding that required blood transfusion (quantity not provided).The gastrointestinal (gi) physician felt the bleeding and ulceration formation were related to the volume of fluid in the balloon".Multiple attempts made to obtain more information from the user facility, without any response received.It is unknown if any other harm was noted, or outcome of patient.No photographs depicting reported complaint issue was received from complainant.

• 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 ; 3365424681
• MDR Report Key: 10435120
• MDR Text Key: 203824096
• Report Number: 1049092-2020-00164
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1