MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT; DIGNISHIELD STOOL MANAGEMENT SYSTEM

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

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 nurse states their facility has been using the dignishield for stool management.They noticed there was one port on the luer lock syringe (that comes in the kit) did not fit.They were unsure which port it was.It was informed to the inquirer that the tray comes with catheter tube assembly, collection bag, 50ml syringe, lubricating jelly syringe (10ml), instructions for use and 1 bottle (1oz) of medi-aire® (biological odor eliminator).Inflation and irrigation ports use a luer lock syringe, sample and flushing port uses a slip tip syringe that was not included.Inquirer states that tray should come with the slip tip syringe or make a note it was needed.They also believe the luer lock syringe included doesn't fit both the inflation and irrigation ports.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect dimensions of assembly od or connector id¿.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: the information provided by bd represents all 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.

Event Description

It was reported that nurse states their facility has been using the dignishield for stool management.They noticed there was one port on the luer lock syringe (that comes in the kit) did not fit.They were unsure which port it was.It was informed to the inquirer that the tray comes with catheter tube assembly, collection bag, 50ml syringe, lubricating jelly syringe (10ml), instructions for use and 1 bottle (1oz) of medi-aire® (biological odor eliminator).Inflation and irrigation ports use a luer lock syringe, sample and flushing port uses a slip tip syringe that was not included.Inquirer states that tray should come with the slip tip syringe or make a note it was needed.They also believe the luer lock syringe included doesn't fit both the inflation and irrigation ports.

• Brand Name: UNKNOWN FECAL MANAGEMENT
• Type of Device: DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16700485
• MDR Text Key: 312872857
• Report Number: 1018233-2023-02378
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other