MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

Catalog Number SMS002

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the ports in the dignishield for the inflation, irrigation and flush were loose.They were not tight in its place as normal.The healthcare professional was not satisfied.Per follow-up information received from ibc on 29nov2023, stated that two products were affected.No injury occurred.

Manufacturer Narrative

The reported event was inconclusive -visual evaluation of the returned photo sample noted one opened (without original packaging), used dignishield.Visual inspection of the three-photo sample noted the inflation port, flush port and the irrigation port assembled to the dignishield catheter as intended.However, unable to evaluate fitting problem from photos provided.The exact root cause could not be identified, since reported event was inconclusive.A potential root cause for this failure mode could be "omitted operation due to inadequate training".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿sms002 bard® instructions for use warning/avertissemen/advertencia there is a potential risk of misconnections with connectors from other healthcare applications, such as intravenous equipment, breathing and driving gas systems, urethral/urinary, limb cuff inflation, neuraxial devices and other enteral and gastric applications.A piston valve connector located on the end of the drainage tube of the catheter attaches to the collection bag hub socket.When the collection bag is disengaged from the catheter, the catheter and bag automatically close to prevent spillage.A bag cap is provided to secure the contents of the collection bag when the catheter is removed.The 50 ml syringe and lubricating jelly syringe are used in the preparation and use of the catheter.The medi-aire® biological odor eliminator may be used as an air freshener in the room.Do not spray on patient or device.The tube clamp is used to retain medication during administration of medication.Directions for use: pump sprayer once or twice.Direct spray away from patient.Contains: water, sd alcohol 40, triethylene glycol, benzethonium chloride, d&c color, tetrasodium edta.Caution: may be harmful if swallowed.Avoid eye contact.Keep out of reach of children.General guidelines: the device may be replaced as needed, to perform patient assessment.For medical or technical questions, please contact medical services and support 800-227-3357.If further information or guidelines are needed, please contact bard medical, at the address below: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 assembled in mexico www.Bardmedical.Com bard, dignishield, medi-aire and permalene are trademarks and/or registered trademarks of c.R.Bard, inc.©2020 c.R.Bard, inc.All rights reserved.11.System care, maintenance, and monitoring of device a.Take note of the black position indicator line that is printed in the proximal segment of the tsz.Observe its relative position to the patient¿s anus.Observe changes in the location of the position indicator band as a means to determine movement of the retention cuff in the patient¿s rectum.This may indicate the need for the cuff or drainage tube to be repositioned.B.Change the collection bag as needed.C.Secure the bag cap onto each used collection bag and discard according to institutional protocol for disposal of medical waste.D.To ensure unobstructed flow of fecal matter from the drainage tube to the collection bag, frequently verify that the catheter and collection bag are positioned so that the catheter is not twisted, kinked, or externally compressed.E.Frequently verify that waste is not accumulating in the catheter drainage tube.F.Verify patient is not lying on drainage tube or ports in such a manner as to potentially cause discomfort or localized prolonged pressure.G.Check the retention cuff volume regularly to ensure proper inflation.¿ h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the ports in the dignishield for the inflation, irrigation and flush were loose.They were not tight in its place as normal.The healthcare professional was not satisfied.Per follow-up information received from ibc on 29nov2023, stated that two products were affected.No injury occurred.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: STOOL MANAGEMENT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18346826
• MDR Text Key: 331069403
• Report Number: 1018233-2023-09004
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMS002
• Device Lot Number: NGGQ0656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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): Other