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

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - 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.H3 other text : the device was not returned.

Event Description

It was reported multiple occurrences of the stool management system leaking, leading to skin irritation and deterioration affecting multiple patients.Provided dates for 2 occurrences, (b)(6) 2023 and (b)(6) 2023.Had at least 2 prior occurrences but unsure of dates.No medical intervention was reported.Per follow up via phone on 29jun2023, it was reported that the night staff disposed the two stool management systems.The two occurrences happened to two different patients, and no harm was done.Even after making sure the connections were tightened, staff members were not able to suction stool from the patients.The customer spoke with the nurse educators for input, but the problems were unresolved.Per additional information received via email on 07aug2023, representative spoke with the local sales representative, who met with this account about their dignishield issues and to make sure they were adequately trained.As they were going through everything, they said they had no issues with training, that they were more than familiar with the product and how to use it.They stated that something was different about the dignishield now vs what they have always used.When they looked at what they had on hand vs the sales reps sample they said the cuff color looked different and that material just below the cuff seemed thinner and stickier.They had a few instances just last week where the stickiness of the material has caused the dignishield tubing to stick together and close off.The sample the sales representative had brought in did not do this.The representative was trying to saw if they could obtain the lot number.

Event Description

It was reported multiple occurrences of the stool management system leaking, leading to skin irritation and deterioration affecting multiple patients.Provided dates for 2 occurrences, ((b)(6) 2023) and ((b)(6) 2023).Had at least 2 prior occurrences but unsure of dates.No medical intervention was reported.Per follow up via phone on (b)(6) 2023, it was reported that the night staff disposed the two stool management systems.The two occurrences happened to two different patients, and no harm was done.Even after making sure the connections were tightened, staff members were not able to suction stool from the patients.The customer spoke with the nurse educators for input, but the problems were unresolved.Per additional information received via email on 07aug2023, representative spoke with the local sales representative, who met with this account about their dignishield issues and to make sure they were adequately trained.As they were going through everything, they said they had no issues with training, that they were more than familiar with the product and how to use it.They stated that something was different about the dignishield now vs what they have always used.When they looked at what they had on hand vs the sales reps sample they said the cuff color looked different and that material just below the cuff seemed thinner and stickier.They had a few instances just last week where the stickiness of the material has caused the dignishield tubing to stick together and close off.The sample the sales representative had brought in did not do this.The representative was trying to saw if they could obtain the lot number.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "tube experiences extreme high temperature for an extended period during transit or storage".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: FECAL MANAGEMENT (DIGNISHIELD)
• 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: 17611741
• MDR Text Key: 321835338
• Report Number: 1018233-2023-06283
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 10/05/2023
• 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