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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD) Back to Search Results
Catalog Number UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/27/2020
Event Type  Injury  
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿materials of construction are not biocompatible¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the fecal management system product ifus were found to be adequate based on past reviews.The device was not returned.
 
Event Description
It was reported that the bard fecal management system was inserted in two covid ecmo patients and it resulted in them having multiple lesions in their colon.These lesions developed massive bleeding that required multiple blood transfusions and procedures to control the bleeding.It was noted that first patient with (b)(6) years of age male inserted the fecal management system on (b)(6) 2020 and removed on (b)(6) 2020.Bleeding required 4 packed red blood cell infusions and one colonoscopy for epinephrine injection and cautery.The device was in use for 22 days.The second patient with (b)(6) years of age male inserted the fecal management system on (b)(6) 2020 and removed on (b)(6) 2020.Bleeding required 44 packed red blood cells, 36 units of cryo, 19 units of platelets, and 10 units of fresh frozen plasma and required 3 colonoscopies for epinephrine injections and cautery.The device was in use for 6 days.Per additional information received via email on 11may2021 from complainant, first patient had a large tear near the anus that bled profusely requiring multiple transfusions and underwent an emergent colonoscopy, and the tear was cauterized.There were no further issues, and the patient was discharged to rehab.The second patient developed a large necrotic ulcer that was resistant to intervention and underwent 5 emergent colonoscopies, 2 interventional radiology interventions, and finally a colectomy that resulted in continued massive bleeding that led to his death.Complainant stated they were no longer using this device in their ecmo patients and have switched to the bard fecal containment device instead.Additional clinical follow ups were attempted on (b)(6) 2021, but no additional information has been received.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿materials of construction are not biocompatible¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the fecal management system product ifus were found to be adequate based on past reviews.Correction ¿ section g : date received by manufacturer should be (b)(6) 2020 instead of (b)(6) 2021 as initially reported.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.
 
Event Description
It was reported that the bard fecal management system was inserted in two covid ecmo patients and it resulted in them having multiple lesions in their colon.These lesions developed massive bleeding that required multiple blood transfusions and procedures to control the bleeding.It was noted that first patient with 33 years of age male inserted the fecal management system on (b)(6) 2020 and removed on (b)(6) 2020.Bleeding required 4 packed red blood cell infusions and one colonoscopy for epinephrine injection and cautery.The device was in use for 22 days.The second patient with 48 years of age male inserted the fecal management system on (b)(6) 2020 and removed on (b)(6) 2020.Bleeding required 44 packed red blood cells, 36 units of cryo, 19 units of platelets, and 10 units of fresh frozen plasma and required 3 colonoscopies for epinephrine injections and cautery.The device was in use for 6 days.Per additional information received via email on (b)(6) 2021 from complainant, first patient had a large tear near the anus that bled profusely requiring multiple transfusions and underwent an emergent colonoscopy, and the tear was cauterized.There were no further issues, and the patient was discharged to rehab.The second patient developed a large necrotic ulcer that was resistant to intervention and underwent 5 emergent colonoscopies, 2 interventional radiology interventions, and finally a colectomy that resulted in continued massive bleeding that led to his death.Complainant stated they were no longer using this device in their ecmo patients and have switched to the bard fecal containment device instead.Additional clinical follow ups were attempted on (b)(6) 2021 and (b)(6) 2021, but no additional information has been received.
 
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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 Key11946526
MDR Text Key255158686
Report Number1018233-2021-03266
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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