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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 SMS002E
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2023
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 air was difficult to remove from the cuff.Attempting to apply negative pressure to the green cuff to remove air before catheter insertion to the patient, but the air came in from somewhere and would not come out.
 
Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for patient treatment.The product had not caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.
 
Event Description
It was reported that air was difficult to remove from the cuff.Attempting to apply negative pressure to the green cuff to remove air before catheter insertion to the patient, but the air came in from somewhere and would not come out.
 
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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 Key16409455
MDR Text Key309914697
Report Number1018233-2023-01039
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue NumberSMS002E
Device Lot NumberNGEZ2072
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
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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