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

Device Problem Biocompatibility (2886)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that one patient had experienced bleeding due to insertion with fecal management system.And also, two patients had experienced pressure injuries along mucosal edge of anal opening.No medical intervention reported.As per additional information received on 25-jan-2021, 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 flexi-seal) 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.It is unknown what medical intervention is provided.

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.H3: the device was not returned.

Event Description

It was reported that one patient had experienced bleeding due to insertion with fecal management system.And also, two patients had experienced pressure injuries along mucosal edge of anal opening.No medical intervention reported.As per additional information received on (b)(6) 2021, 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 flexi-seal) 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.It is unknown what medical intervention is provided.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to "materials of construction are not biocompatible, inadequate biological evaluation".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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.

• Brand Name: UNKNOWN FECAL MANAGEMENT
• Type of Device: UNKNOWN FECAL MANAGEMENT
• 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: 17358043
• MDR Text Key: 319380620
• Report Number: 1018233-2023-05308
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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