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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 Entrapment of Device (1212); Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Patient Problems Incontinence (1928); Discomfort (2330); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
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 after 2 nurses boosted the patient in the bed, the fecal management system (fms) was fallen out.The patient reported discomfort immediately in her rectal area.Both nurses observed that the fecal management system (fms) had become dislodged and that the green inflatable ring was not intact and it appeared that pieces of the green rubber like material were missed the nurse reported concern of a portion of the fecal management system (fms) remained in the patients rectum to the treatment team.An x-ray of the pelvis and abdomen were ordered and confirmed the fecal management system (fms) was still in the patient.The patient continued to be incontinent of stool intermittently throughout the day while it was hoped that the material would passed.At the end of shift the material still remained in the patient.It was confirmed that there is no sample for return.The fecal management system (fms) was in placed for 4 days before the event.Ultimately the piece left in the patient was passed naturally.
 
Event Description
It was reported that after 2 nurses boosted the patient in the bed, the fecal management system (fms) was fallen out.The patient reported discomfort immediately in her rectal area.Both nurses observed that the fecal management system (fms) had become dislodged and that the green inflatable ring was not intact and it appeared that pieces of the green rubber like material were missed the nurse reported concern of a portion of the fecal management system (fms) remained in the patients rectum to the treatment team.An x-ray of the pelvis and abdomen were ordered and confirmed the fecal management system (fms) was still in the patient.The patient continued to be incontinent of stool intermittently throughout the day while it was hoped that the material would passed.At the end of shift the material still remained in the patient.It was confirmed that there is no sample for return.The fecal management system (fms) was in placed for 4 days before the event.Ultimately the piece left in the patient was passed naturally.
 
Manufacturer Narrative
The device was not returned for evaluation.The reported event could not be confirmed.A potential failure mode could be ¿material tears¿ with a potential root cause of ¿material too thin¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿instructions for use preparation of sms prior to insertion.Verify the retention cuff has been completely deflated.This can be done by squeezing the cuff to ensure there is no residual air inside the device.If air remains within the cuff, attach the 60 ml syringe to the green inflation port and withdraw all remaining air from the cuff.After the cuff has been fully deflated, fill the syringe with 45 ml of water and set aside.Using a permanent marker, record the catheter insertion date on the label located on the piston valve connector." 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
Type of Device
DIGNISHIELD
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10055683
MDR Text Key190923497
Report Number1018233-2020-03190
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 06/17/2020
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? Yes
Device Operator Health Professional
Device Expiration Date12/01/2022
Device Model NumberSMS002
Device Catalogue NumberSMS002
Device Lot NumberNGDY0246
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/24/2020
Initial Date FDA Received05/14/2020
Supplement Dates Manufacturer Received05/27/2020
Supplement Dates FDA Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight77
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