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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
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Perforation (2001); Patient Problem/Medical Problem (2688)
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 nurse gave lactulose enemas as ordered every 4 hours during her shift through the port clamped with a hemostat which was labeled balloon inflation.When discovered by the oncoming shift nurse, the oncoming nurse immediately removed 325cc of lactulose from the balloon port.When the rectal tube was removed the nurse noted the bright red blood that came out with the tube.The bright red blood continued through the nurses shift and the patient had a ct scan of the abdomen completed.The ct results showed a perforated rectum and significant rectal edema.The treatment was not listed on the medwatch and no contact information was available to request additional details of this event.
 
Event Description
It was reported that the nurse gave lactulose enemas as ordered every 4 hours during her shift through the port clamped with a hemostat which was labeled balloon inflation.When discovered by the oncoming shift nurse, the oncoming nurse immediately removed 325cc of lactulose from the balloon port.When the rectal tube was removed the nurse noted the bright red blood that came out with the tube.The bright red blood continued through the nurses shift and the patient had a ct scan of the abdomen completed.The ct results showed a perforated rectum and significant rectal edema.The treatment was not listed on the medwatch and no contact information was available to request additional details of this event.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the label review was determined to be adequate based on past reviews.
 
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Brand Name
UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
Type of Device
FECAL MANAGEMENT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8233002
MDR Text Key132580556
Report Number1018233-2019-00207
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 other,user facility
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer Received01/21/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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