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

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient had an injury from fecal management system (fms) in ccu.The complainant felt it was the fragility of the patient involved.This device was in place for 6 days, the patient had a flexiseal in for 3 days prior to placement of dignishield.Per additional information received from the complainant via email on 12-jun-2020, the nurse noted blood stains on the patient's under pad and a small pink area was noted on the rectum at six o'clock.This was discovered by the night nurse on (b)(6) 2020.When the sms tubing was pulled to the side, it revealed "mucous membrane injury" with a gray base that extended upwards along the path of the tubing.The device was removed, but the wound was not measured by the nurse that night.On (b)(6) 2020, the patient was assessed by a wound care nurse who noted a 0.5cm x 0.5cm area of red tissue with no slough, but she was unable to visualize the patient's internal anatomy.A surgical consult was suggested, however, due to the patient's condition, they did not pursue a more intensive exam.His bowels functioned as they did prior.Patient had a previous fms system in place on (b)(6) 2020, but she was not sure where it came from.It was removed due to output slowing on (b)(6) 2020.The patient had several days without any other device in place.On (b)(6) 2020, the dignishield device was placed.The wound was noted on (b)(6) 2020.The patient was not lying prone and the unit was very familiar with using this device and have not had issues.When the patient was assessed again on (b)(6) 2020, no injury was visible and no medical intervention was necessary.

Event Description

It was reported that the patient had an injury from fecal management system (fms) in ccu.The complainant felt it was the fragility of the patient involved.This device was in place for 6 days, the patient had a flexiseal in for 3 days prior to placement of dignishield.Per additional information received from the complainant via email on (b)(6)2020 , the nurse noted blood stains on the patient's under pad and a small pink area was noted on the rectum at six o'clock.This was discovered by the night nurse on (b)(6)2020.When the sms tubing was pulled to the side, it revealed "mucous membrane injury" with a gray base that extended upwards along the path of the tubing.The device was removed, but the wound was not measured by the nurse that night.On (b)(6)2020 , the patient was assessed by a wound care nurse who noted a 0.5cm x 0.5cm area of red tissue with no slough, but she was unable to visualize the patient's internal anatomy.A surgical consult was suggested, however, due to the patient's condition, they did not pursue a more intensive exam.His bowels functioned as they did prior.The patient had a previous fms system in place on (b)(6)2020 , but she was not sure where it came from.It was removed due to output slowing on (b)(6)2020.The patient had several days without any other device in place.On(b)(6)2020 , the dignishield device was placed.The wound was noted on(b)(6)2020.The patient was not lying prone and the unit was very familiar with using this device and have not had issues.When the patient was assessed again on (b)(6)2020 , no injury was visible and no medical intervention was necessary.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿materials of construction are not biocompatible.¿ it was unknown whether the device had met specifications.The product used for the treatment purposes.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.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: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10186896
• MDR Text Key: 196380501
• Report Number: 1018233-2020-04036
• 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,use
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other