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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 COLLECTION BAGS; DIGNISHIELD COLLECTION BAG
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C.R. BARD, INC. (COVINGTON) -1018233 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM COLLECTION BAGS; DIGNISHIELD COLLECTION BAG Back to Search Results
Model Number SMS2B1L
Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2020
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 the dignishield rectal tube bowel irrigation port for bowel medication allegedly leaked while attempting to inject diluted medication with a luer-lock syringe.Supposedly, the valve in the port came out and would be attached to the syringe.However, if replaced it would leak again.The rectal tube was replaced and kept to be submitted back to the company for assessment.
 
Event Description
It was reported that the dignishield rectal tube bowel irrigation port for bowel medication allegedly leaked while attempting to inject diluted medication with a luer-lock syringe.Supposedly, the valve in the port came out and would be attached to the syringe.However, if replaced it would leak again.The rectal tube was replaced and kept to be submitted back to the company for assessment.
 
Manufacturer Narrative
Per review, bard/bd has determined that this mdr is a duplicate record and was previously 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.
 
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Brand Name
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM COLLECTION BAGS
Type of Device
DIGNISHIELD COLLECTION BAG
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10228228
MDR Text Key198086818
Report Number1018233-2020-04306
Device Sequence Number1
Product Code KNT
UDI-Device Identifier00801741045967
UDI-Public(01)00801741045967
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 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSMS2B1L
Device Catalogue NumberSMS2B1L
Device Lot NumberNGEN4794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2020
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received07/03/2020
Supplement Dates Manufacturer Received07/02/2020
Supplement Dates FDA Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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