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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM Back to Search Results
Catalog Number SMS002
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2024
Event Type  malfunction  
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.
 
Event Description
It was reported that while using dignishield for a burned icu patient, the device caused injury in the lower perianal area.The probe leaves the body with the cuff inflated, inflated it up to 60 cc.The probe leaked.Since it has no air escape, the bag inflates.The finger hook system was missing to install (flexiseal type).The material was rigid, and the probe was constantly clogged, which made it necessary to remove, wash and reposition continuously.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be ¿inspection results (measurement, testing data) not verified by iqa assignee error of inspector¿.However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.A labeling review was not performed because labeling could not have prevented the reported failure.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.
 
Event Description
It was reported that while using dignishield for a burned icu patient, the device caused injury in the lower perianal area.The probe leaves the body with the cuff inflated, inflated it up to 60 cc.The probe leaked.Since it has no air escape, the bag inflates.The finger hook system was missing to install (flexiseal type).The material was rigid, and the probe was constantly clogged, which made it necessary to remove, wash and reposition continuously.
 
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Brand Name
BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Type of Device
STOOL MANAGEMENT SYSTEM
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 Key19033036
MDR Text Key339252567
Report Number1018233-2024-01820
Device Sequence Number1
Product Code KNT
UDI-Device Identifier00801741045943
UDI-Public(01)00801741045943
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSMS002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2024
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 Number1
Patient Outcome(s) Other;
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