MAUDE Adverse Event Report: C. R. BARD, INC. DIGNISHIELD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number SMS002

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 02/29/2020

Event Type  No Answer Provided  

Event Description

Bedside nurse was in patient's room right after handoff was given around 0730.Pt expressed affirmation that she would like to be boosted in bed.Bedside nurse and another rn laid the hob flat and each grabbed a side of the body length chux and draw cloth that the pt was laying on.The pt was boosted and the fms fell out.Pt was not slid along any surface.Pt reported discomfort immediately in her rectal area.Both rns observed that the 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 missing.The fms was placed in the trash for later inspection and attention was turned to cleaning up the pt and mitigating her pain.During the process the defective fms was accidentally disposed of with the other contaminated bedding material.Bedside nurse reported concern of a portion of the fms remaining in the pts rectum to treatment team.An x-ray of the pelvis and abdomen were ordered and remaining portion of the fms were seen.Pt continued to be incontinent of stool intermittently throughout the day while it was hoped that the material would be passed.At end of shift the material still remained in the pt's rectum.

• Brand Name: DIGNISHIELD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 9962126
• MDR Text Key: 187715505
• Report Number: 9962126
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: SMS002
• Device Lot Number: NGDY0246 ORNGDW1895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Event Location: Other
• Date Report to Manufacturer: 04/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA