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

Model Number SMS002

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Vomiting (2144); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bd represents all of 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 dignishield was in place from (b)(6) 2020- (b)(6) 2020.The injury was noted on abdominal ct on the 14th due to nausea, vomiting and bleeding from the rectum.The patient reportedly had a blood stream infection that was being contributed to a gut source most likely the site, and antibiotic treatment was ongoing.The patient was reportedly not a candidate for a scope of surgery at the time due to his clinical condition.

Event Description

It was reported that the dignishield was in place from (b)(6)2020 -(b)(6)2020.The injury was noted on abdominal ct on the 14th due to nausea, vomiting and bleeding from the rectum.The patient reportedly had a blood stream infection that was being contributed to a gut source most likely the site, and antibiotic treatment was ongoing.The patient was reportedly not a candidate for a scope of surgery at the time due to his clinical condition.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿materials of construction selected are not biocompatible (bioincompatible)¿ with a potential root cause of "materials of construction are not biocompatible".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.¿ do not use on patients with suspected or confirmed rectal mucosa impairment, i.E.Severe proctitis, ischemic proctitis, mucosal ulcerations.¿ do not use on patients with indwelling rectal or anal device (e.G.Thermometer) or delivery mechanism (e.G.Suppositories) or enemas in place.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.¿ do not over inflate retention cuff.¿ use only gravity or slow manual irrigation.Do not connect mechanical pumping devices to catheter irrigation port.Do not irrigate patient with compromised intestinal wall integrity.¿ rectal bleeding should be investigated to ensure no evidence of pressure necrosis from the device.Discontinuation of use is recommended if pressure necrosis is evident.¿ abdominal distention that occurs while using the device should be investigated.¿ prolonged traction on the catheter may result in the retention cuff migrating into the anal canal which may result in mucosal lesion, temporary or permanent clinical sphincter dysfunction, or catheter expulsion.¿ solid or soft-formed stool cannot pass through the catheter and will obstruct the opening.The use of the device is not indicated for patients with solid or soft formed stool.¿ single use only.Do not reuse.Reuse and/or packaging may create a risk possibly resulting in patient or user infection.Structural integrity and/or essential material and design characteristics of the device, may be compromised, which may lead to device failure and/or lead to injury, illness or death of the patient." h11:section a through f - the information provided by bd represents all of 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.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9683039
• MDR Text Key: 178205690
• Report Number: 1018233-2020-00872
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMS002
• Device Catalogue Number: SMS002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention