MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)

Catalog Number UNKNOWN

Device Problem Deflation Problem (1149)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that one patient had experienced bleeding due to insertion with facal management system.And also two patient had experienced pressure injuries along mucosal edge of anal opening.No medical intervention reported.As per additional information received on 25jan2021, the customer reported that the first incidence was bleeding from the insertion of the device.This happened early on in the launch of the product and i believe it may have had to do with a learning curve on the part of the staff and also mentioned that the insertion technique was challenging and the nurses used a finger slot to insert ( with the flexiseal) and the number of attempts to place the device was more than we would have liked so i wonder if too many attempts could have caused the bleeding.The other two issues were from perennial ulcers placed in patients with hemorrhoids and last week one more patient has experienced perennial ulcers.Additionally the facility has also had two issues with removal of the device from the patient rectum.The first patient greatly provided maneuvers that helped in removal.The port was cut and the cuff drained for easy removal and later lubricant had to be used around the anal opening to help along.The second patient had more complicated so nurse had to call colon rectal and have them come up to remove the device despite maneuvers were used on patient.Apparently the device was like a suction cup and somehow migrated onto the wall of the rectum.The surgeon used a lubricated glove and inched it away and was able to release the suction.In both cases i do not believe any harm was sustained.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿inflation lumen is kinked¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that one patient had experienced bleeding due to insertion with facal management system.And also two patient had experienced pressure injuries along mucosal edge of anal opening.No medical intervention reported.As per additional information received on 25jan2021, the customer reported that the first incidence was bleeding from the insertion of the device.This happened early on in the launch of the product and i believe it may have had to do with a learning curve on the part of the staff and also mentioned that the insertion technique was challenging and the nurses used a finger slot to insert ( with the flexiseal) and the number of attempts to place the device was more than we would have liked so i wonder if too many attempts could have caused the bleeding.The other two issues were from perennial ulcers placed in patients with hemorrhoids and last week one more patient has experienced perennial ulcers.Additionally the facility has also had two issues with removal of the device from the patient rectum.The first patient greatly provided maneuvers that helped in removal.The port was cut and the cuff drained for easy removal and later lubricant had to be used around the anal opening to help along.The second patient had more complicated so nurse had to call colon rectal and have them come up to remove the device despite maneuvers were used on patient.Apparently the device was like a suction cup and somehow migrated onto the wall of the rectum.The surgeon used a lubricated glove and inched it away and was able to release the suction.In both cases i do not believe any harm was sustained.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: UNKNOWN FECAL MANAGEMENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11349225
• MDR Text Key: 232576331
• Report Number: 1018233-2021-00665
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other