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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
Model Number SMS002
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 dignishield cuff would not deflate after approximately 2 days of placement.The nurse obtained deflation recommendations from ms&s, which resolved the issue and allowed for removal of the dignishield.No medical intervention was reported.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿10.Removal of device a.To remove the catheter from the rectum, the retention cuff must be deflated.1) attach the 60 ml syringe to the green inflation port, and slowly withdraw all water from the retention cuff.(figure 13).B.Make sure the inflation port remains parallel to the catheter in order to prevent kinking in the tubing and blockage of fluid.Refer to ideal patient positioning described in step 3a.1) once you have ensured the cuff is fully deflated, disconnect the syringe and discard.2) to facilitate removal, you may add an appropriate amount of lubricant to the anal sphincter prior to pulling back on the catheter to remove the cuff.3) grasp the catheter as close to the patient as possible and slowly slide the cuff out of the anus.Dispose of the device in accordance with institutional protocol for disposal of medical waste.".
 
Event Description
It was reported that the dignishield cuff would not deflate after approximately 2 days of placement.The nurse obtained deflation recommendations from ms&s, which resolved the issue and allowed for removal of the dignishield.No medical intervention was reported.
 
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Brand Name
BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Type of Device
DIGNISHIELD
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8438600
MDR Text Key139420992
Report Number1018233-2019-01472
Device Sequence Number1
Product Code KNT
UDI-Device Identifier00801741045943
UDI-Public(01)00801741045943
Combination Product (y/n)N
PMA/PMN Number
K133251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSMS002
Device Catalogue NumberSMS002
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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