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

Catalog Number SMS002

Device Problem Complete Blockage (1094)

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

Event Date 02/21/2024

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 while using dignishield for a burned icu patient, the device caused injury in the lower perianal area.The probe leaves the body with the cuff inflated, inflated it up to 60 cc.The probe leaked.Since it has no air escape, the bag inflates.The finger hook system was missing to install (flexiseal type).The material was rigid, and the probe was constantly clogged, which made it necessary to remove, wash and reposition continuously.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿irrigation lumen occluded at the cuff leak at the jumper in the ts zone punctured lumen".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications do not use for more than 29 consecutive days.The uninterrupted use for this device, including immediate replacement with the same or an identical device, is intended to be 29 days or less.Do not use on patients known to be sensitive to or allergic to any components within the system.Do not use on patients who had lower large bowel or rectal surgery within the last year.Do not use on patients with any rectal or anal injury, severe rectal or anal stricture or stenosis(or on any patient if the distal rectum cannot accommodate the inflated cuff), confirmed rectal or anal tumor, severe hemorrhoids, or fecal impaction.Warnings: 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.Do not use if package is opened or damaged.Do not use improper amount or type of fluids for irrigation/flush or cuff inflations.Never use hot liquids.Instructions for use: preparation of sms prior to insertion.Collection bag connection.Preparation of patient.Insertion of device.Irrigation of the retention cuff.Flushing of the drainage tube.Administration of medication.Stool sampling.Removal/replacement of the collection bag.Removal of device.System care, maintenance, and monitoring of device".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 device was not returned.

Event Description

It was reported that while using dignishield for a burned icu patient, the device caused injury in the lower perianal area.The probe leaves the body with the cuff inflated, inflated it up to 60 cc.The probe leaked.Since it has no air escape, the bag inflates.The finger hook system was missing to install (flexiseal type).The material was rigid, and the probe was constantly clogged, which made it necessary to remove, wash and reposition continuously.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD 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: 19031073
• MDR Text Key: 339227834
• Report Number: 1018233-2024-01792
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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